Associate Labeling Specialist - Regulatory Affairs Applied Medical Resources CorpAssociate Labeling Specialist - Regulatory AffairsRancho Santa Margarita, CA$71,000–$80,000 / yearThe Associate Labeling Specialist works cross-functionally to support labeling projects from design input through final approval, making this an ideal opportunity for professionals with a background in regulatory affairs, quality assurance, or technical writing in the medical device industry. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.
Associate Labeling Specialist – Regulatory Affairs Applied MedicalAssociate Labeling Specialist – Regulatory AffairsRancho Santa Margarita, California$71,000–$80,000 / yearp style="margin:0px">. The Associate Labeling Specialist works cross-functionally to support labeling projects from design input through final approval, making this an ideal opportunity for professionals with a background in regulatory affairs, quality assurance, or technical writing in the medical device industry.
Sr. Regulatory Affairs Specialist Envista Holdings CorpSr. Regulatory Affairs SpecialistBrea, CA$94,500–$141,800 / yearEnvista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envistas internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
NewRegulatory Affairs Specialist II Envista Holdings CorpRegulatory Affairs Specialist IIBrea, CA$85,800–$104,800 / yearThis individual is responsible for obtaining global regulatory registrations/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
Regulatory Affairs Specialist, Sr. Glidewell DentalRegulatory Affairs Specialist, Sr.Irvine, CaliforniaBehind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections).
NewSenior Regulatory Affairs Specialist Quidelortho CorpSenior Regulatory Affairs SpecialistCAp>QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. Interacts with regulatory agencies regarding product registrations, licensures, and permits and supports regulatory compliance to QSR, ISO, CMDR, MDSAP, IVDD/IVDR, CFR and other worldwide regulatory requirements.
Junior Regulatory Affairs Specialist Pro-Dex IncJunior Regulatory Affairs SpecialistIrvine, CA$60,000–$65,000 / yearResponsibilities include support for QA/RA related operational activities within the Quality System that may include processes such as recall investigations/activities, Audits, Deviations and Process/Product Validations and Product Development/Design Control deliverables. Experience in industrial hygiene/safety, government regulations, EU MDR, ISO, MDSAP, operational auditing, work flow analysis, technical writing, and manufacturing operations preferred.
NewSr. Regulatory Affairs Specialist - Ad/Promo Prolacta BioscienceSr. Regulatory Affairs Specialist - Ad/PromoCity of Industry, California$112,000–$125,000li>A minimum of 6 years of relevant regulated industry experience in Regulatory Affairs with exposure to advertising/promotional review, labeling, product claims, regulatory notifications, submissions, controlled documentation, or quality/regulatory compliance activities. Review assigned advertising, promotional, labeling, packaging, digital, scientific, educational, technical, and other external-facing materials for regulatory compliance, intended use, claim support, accuracy, balance, and consistency with approved source documents.
NewRegulatory Affairs Specialist II Envista DentistryRegulatory Affairs Specialist IIBrea, CaliforniaThis individual is responsible for obtaining global regulatory registrations/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
Regulatory Affairs Specialist Broadata CommunicationsRegulatory Affairs SpecialistTorrance, CaliforniaThis role will support Class I and Class II medical device programs, including technical documentation, design history files, change control, risk management, supplier documentation, labeling review, customer regulatory requests, and audit readiness. Experience with Class II medical devices, 510(k) support, IEC 60601-1, EU MDR technical documentation, or customer-driven regulatory submissions is highly preferred.
Senior Staff Regulatory Affairs Specialist Stryker CorpSenior Staff Regulatory Affairs SpecialistIrvine, CA$126,600–$210,900 / yearHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. As a Senior Staff Regulatory Affairs Specialist, you will influence global regulatory strategy across the full product lifecycle while partnering closely with product development, quality, and clinical teams.
Sr. Specialist, Regulatory Affairs Metagenics LLCSr. Specialist, Regulatory AffairsAliso Viejo, CAp>Industry Surveillance: Monitors competitive claims, FDA's and FTC''s actions, litigation, news releases and other sources, as they relate to the current science of Metagenics-related products and challenges to relevant product claims, to ensure that Metagenics limits its exposure for product claims both domestically and internationally. The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs.
Sr. Specialist, Regulatory Affairs MetagenicsSr. Specialist, Regulatory AffairsAliso Viejo, Californiaul>Monitors competitive claims, FDA’s and FTC's actions, litigation, news releases and other sources, as they relate to the current science of Metagenics-related products and challenges to relevant product claims, to ensure that Metagenics limits its exposure for product claims both domestically and internationally. Click here for Metagenics’ California Data Privacy Act Disclosure.
Regulatory Affairs Specialist V eTeam Inc.Regulatory Affairs Specialist VLake Forest, CAThe role involves setting or executing regulatory strategy, leading and managing as a strategist, ensuring local product registration, facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. A self-starter, assertive leader who will be accountable for the end-to-end regulatory support for the anterior/posterior ophthalmologic products, including new products, sustaining legacy products, and improvements to the product lines.
Regulatory Affairs Specialist (FDA/Medical Device) Staffmark Group LlcRegulatory Affairs Specialist (FDA/Medical Device)Torrance, CASee our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. An established consulting firm in Torrance, serving a prestigious roster of international clients in the medical device and pharmaceutical sectors, are looking for a Regulatory Affairs Specialist who values precision, professionalism, and long-term career growth.
Regulatory Affairs and Quality Assurance Specialist SprintRay IncRegulatory Affairs and Quality Assurance SpecialistHuntington Beach, CA$90,000–$120,000 / yearp>To All Recruitment Agencies: Without a written agreement signed by an officer of SprintRay: a) SprintRay does not accept resumes from recruiting agencies, headhunters, or any other party expecting payment in the event SprintRay speaks with or hires a candidate from such submitted resume; b) SprintRay is not responsible for any fees related to unsolicited resumes or related Terms of Service, and c) Unsolicited resumes received will be considered the property of SprintRay and will be processed accordingly. Whether we're building next-generation AI tools, designing new materials, or supporting our customers on the front lines, we're united by the same passion-transforming digital dentistry and having fun while we do it.
Regulatory Affairs Specialist Nihon Kohden CorpRegulatory Affairs SpecialistIrvine, CA$80,000–$100,000 / yearp>Physical: Generally, may require some reaching, bending, stooping, squatting, crawling, kneeling, pushing, pulling, lifting, carrying up to 20 pounds, finger dexterity, repetitive motions, standing, walking, sitting, hearing, visual acuity, and color vision. Work with RA Leadership and other members of the RA team to set strategy for regulatory approval to introduce new products to market, evaluate regulatory requirements and prepare regulatory submissions.
Regulatory Affairs and Quality Assurance Specialist SprintRayRegulatory Affairs and Quality Assurance SpecialistHuntington Beach, California$90,000–$120,000p>Without a written agreement signed by an officer of SprintRay: a) SprintRay does not accept resumes from recruiting agencies, headhunters, or any other party expecting payment in the event SprintRay speaks with or hires a candidate from such submitted resume; b) SprintRay is not responsible for any fees related to unsolicited resumes or related Terms of Service, and c) Unsolicited resumes received will be considered the property of SprintRay and will be processed accordingly. Participate in internal audits, supplier audits, and preparation for external audits (FDA, Notified Body, MDSAP).
Specialist, International Regulatory Affairs THV Edwards Lifesciences CorpSpecialist, International Regulatory Affairs THVIrvine, CA$74,000–$104,000 / yearWorking in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients' lives. How you will make an impact: Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.
Specialist, Regulatory Affairs Surgical Edwards Lifesciences CorpSpecialist, Regulatory Affairs SurgicalIrvine, CA$74,000–$104,000 / yearp>How you will make an impact: Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients' lives.
NewSenior Specialist, Regulatory Affairs (THV) JenaValve TechnologySenior Specialist, Regulatory Affairs (THV)Irvine, CAli>Organizational & People Development: Function as both team player and leader; Provide informal feedback; Challenge the status quo; Strive for continuous professional development; Recognize the contributions of others; Set and achieve challenging goals. Job Responsibilities: Under supervision, lead the preparation, submission, and maintenance of high-quality global filings for investigational device authorizations and registrations, annual reports, and amendments/supplements, communicating with regulatory authorities as applicable.
Senior Specialist, Regulatory Affairs Surgical Edwards LifesciencesSenior Specialist, Regulatory Affairs SurgicalIrvine, CA$92,000–$130,000 / yearPrepare, compile, and support global regulatory submissions for assigned products, including: U.S. submissions (e.g., 510(k)s, IDEs, PMAs, PMA supplements, annual reports) EU submissions under the Medical Device Regulation (MDR) (e.g., Technical Documentation, Design Dossiers, STEDs, clinical evaluation documentation, and responses to Notified Body questions) Support CE marking activities and interactions with Notified Bodies for Class III implantable devices. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.
SENIOR REGULARY AFFAIRS SPECIALIST LGM Pharma LLCSENIOR REGULARY AFFAIRS SPECIALISTIrvine, CAli>Ensures compliance with product post-marketing approval requirements, annual reports, drug listings, labeling, pharmacopeia changes (pre and post approval), etc. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.
Information Specialist DexCom IncInformation SpecialistCA$100,700–$167,900 / yearAs an Information Specialist, you'll play a critical role at the intersection of science, research, and strategy-partnering with colleagues across Scientific Communications, Regulatory Affairs, and Clinical teams worldwide. Where you come in: Lead regulatory literature search strategy and execution for key submissions (e.g., SOTA, CER), ensuring outputs are comprehensive, traceable, and aligned with submission timelines.
Regulatory Affairs Manager I Alcon IncRegulatory Affairs Manager ILake Forest, CAThe Manager I, Regulatory Affairs Strategy (Professional Path) ), reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily responsible for coordinating regulatory affairs activities, including product submissions, renewals, and updates, while ensuring compliance and competitive advantage. Collect and analyze regulatory intelligence for China to ensure product compliance and engage in industry associations like Advanced Medical Technology Association (AdvaMed) and Asia Pacific Medical Technology Association (APACMed).
Senior Manager, Regulatory Affairs TMTT Edwards LifesciencesSenior Manager, Regulatory Affairs TMTTIrvine, CA$145,000–$205,000 / yearWorking in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives. Includes representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including providing alternatives for meeting regulatory requirements and resolving complex conflicts between those requirements and development issues.
Sr. Associate II, Regulatory Affairs Strategy Alcon IncSr. Associate II, Regulatory Affairs StrategyIrvine, CAIn this role, you will develop strong scientific and technical product knowledge and serve as a key resource to country Regulatory Affairs associates by providing regulatory guidance and information. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.
Principle Regulatory Affairs Strategy Associate Sunrise Systems IncPrinciple Regulatory Affairs Strategy AssociateLake Forest, CA$79.71–$83.33 / hourThe Principle Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product registration and facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. Coordinate regulatory activities, including product submissions, renewals, and updates, by liaising with plants, agents, and governmental authorities to ensure timely submissions and approvalsOversee promotional material approval for Alcon ME/KSA portfolio, ensuring ethical conduct and compliance with national and international laws, codes, and regulations.
Senior Manager, Regulatory Affairs Strategy Alcon IncSenior Manager, Regulatory Affairs StrategyLake Forest, CAManager, Regulatory Affairs Strategy (Professional Path), reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product registration and facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. In this role, a typical day will include: A self-starter, assertive leader who will be accountable for the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.
Senior Regulatory Affairs Associate Alcon IncSenior Regulatory Affairs AssociateLake Forest, CAAssociate, Regulatory Affairs Strategy (Professional Path) , reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily responsible for coordinating regulatory compliance for Alcon's product portfolio, managing local initiatives, and supporting business requests for product and regulatory information. Data requests to R&D for tender applications, one-off requests for country-specific technical information, maintenance of project status master slide deck for regional RA calls, drafting (not signing) explanation letters, and other administrative requirements for HA queries.
Manager II, Regulatory Affairs the Tarsanet Internal Career CenterManager II, Regulatory AffairsIrvine, CaliforniaRemoteAssist in performing and managing the initial part of the workflow (Initial QC, routing, scheduling meetings, etc.) in the Veeva system for material review and approval of the materials submitted from the assigned business units. Serve as the Regulatory point of contact for the regulatory promotional perspective and rationale at regulatory project team meetings, labeling meetings, brand team meetings, as needed.
Principle Regulatory Affairs Strategy Associate Artech LLCPrinciple Regulatory Affairs Strategy AssociateLake Forest, CA$72–$75 / hourThe Principle Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product registration and facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. Expectations / Responsibilities: A self-starter, assertive leader who will be accountable for the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.
Regulatory Affairs Manager I Alcon ResearchRegulatory Affairs Manager ILake Forest, Californiap style="text-align:inherit"/>Find Jobs for Contingent Worker. The Manager I, Regulatory Affairs Strategy (Professional Path) ), reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily responsible for coordinating regulatory affairs activities, including product submissions, renewals, and updates, while ensuring compliance and competitive advantage.
Senior Manager Regulatory Affairs US Advertising and Promotion - US Specialty AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - US SpecialtyIrvine, CAOversees the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - ImmunologyIrvine, CAp>US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Director, Regulatory Affairs Strategy Alcon IncDirector, Regulatory Affairs StrategyLake Forest, CAAs a Director, Regulatory Affairs Strategy (Management Path) supporting Alcons Quality & Regulatory Affairs organization, this onsite role based at our Lake Forest, California main campus is responsible for developing and executing regulatory strategies to obtain and maintain product approvals across Alcons franchise portfolios. Primary responsibilities include providing strategic regulatory leadership across the product lifecycle, preparing and overseeing high-quality regulatory submissions, and serving as the primary liaison with global health authorities to support timely product approvals.
Regulatory Affairs & Compliance Analyst, Policies & Procedures CalOptimaRegulatory Affairs & Compliance Analyst, Policies & ProceduresOrange, CA$68,015–$108,824 / yearp>We are hoping you will join us as a Regulatory Affairs & Compliance Analyst, Policies & Procedures and help shape the future of healthcare where you'll be an integral part of our OOC - Policies & Procedures team, helping to strive for excellence while we serve our member health with dignity, respecting the value and needs of each of our members through collaboration with our providers, community partners and local stakeholders. Bachelor's degree in health services administration, public health, public policy or related field PLUS 3 years of experience in the health care industry in a public or regulatory affairs role, including experience in policies and procedures development, required; an equivalent combination of education and experience sufficient to successfully perform the essential duties of the position such as those listed above may also be qualifying.
Regulatory Affairs & Quality Assurance Manager University of California, IrvineRegulatory Affairs & Quality Assurance ManagerOrange, CaliforniaResponsibilities: Under the general direction of the Assistant Director of Clinical Research Operations of the UCI Center for Clinical Research (CCR), the Manager of Regulatory Affairs and Quality Assurance is responsible for all clinical research regulatory and quality assurance operational matters in fulfilling the mission of CCR under the University of California, Irvine - School of Medicine and the overall UC Irvine Health enterprise. *Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.
Manager Regulatory Affairs Device-Combination Products AbbVie IncManager Regulatory Affairs Device-Combination ProductsIrvine, CARepresents Device Regulatory Affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Senior Regulatory Affairs Associate Alcon ResearchSenior Regulatory Affairs AssociateLake Forest, CaliforniaAssociate, Regulatory Affairs Strategy (Professional Path) , reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily responsible for coordinating regulatory compliance for Alcon's product portfolio, managing local initiatives, and supporting business requests for product and regulatory information. Find Jobs for Contingent Worker.
Senior Manager, Regulatory Affairs Strategy Alcon ResearchSenior Manager, Regulatory Affairs StrategyLake Forest, CaliforniaManager, Regulatory Affairs Strategy (Professional Path), reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product registration and facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. Find Jobs for Contingent Worker.
Senior FSQA Specialist In-N-Out Burgers IncSenior FSQA SpecialistChino, CA$96,239–$112,000 / yearp>Requirement Ability to lift a minimum of 70 pounds Occasionally exposed to working in high precarious places tight constricted areas outdoor weather conditions fumes or airborne particles Position requires frequent lifting walking reaching standing climbing stooping bending kneeling working near moving mechanical parts Cold working conditions Ability to withstand prolonged work assignments in temperatures as low as 36 degrees Fahrenheit Frequently exposed to wet humid conditions non-weather. Minimum of 5 years experience in meat operations or beef-focused facility HACCP certification Required Knowledge of USDA-FSIS and regulatory affairs Required A working knowledge of beef regulatory affairs and beef specific food safety principles and best practices Required Knowledge of Public Health Information System PHIS Excellent verbal and written communications Proven relationship building and leadership experience in a team setting Strong time management and prioritization MS Office - Intermediate level.
NewClinical Complaint Specialist Masimo CorpClinical Complaint SpecialistIrvine, CA$80,000–$100,000 / yearThis role applies clinical expertise to evaluate complaint events, assess potential patient impact, determine regulatory reportability, support investigations, and ensure accurate complaint documentation. Collaborate with Quality, Regulatory Affairs, Medical Affairs, Clinical Affairs, Engineering, Manufacturing, and other cross-functional teams to support complaint investigations and resolution activities.
Manager II, Regulatory Affairs Strategy Alcon IncManager II, Regulatory Affairs StrategyCA$105,000–$175,000 / yearYou will support regulatory strategy execution with a focus on medical device consumables and accessories within the Surgical franchise, partnering cross‑functionally to ensure alignment with evolving regulatory expectations. Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness.
Director, Regulatory Affairs Strategy Alcon ResearchDirector, Regulatory Affairs StrategyLake Forest, CaliforniaAs a Director, Regulatory Affairs Strategy (Management Path) supporting Alcon’s Quality & Regulatory Affairs organization, this onsite role based at our Lake Forest, California main campus is responsible for developing and executing regulatory strategies to obtain and maintain product approvals across Alcon’s franchise portfolios. Primary responsibilities include providing strategic regulatory leadership across the product lifecycle, preparing and overseeing high‑quality regulatory submissions, and serving as the primary liaison with global health authorities to support timely product approvals.
Engineering Manager, FAA Regulatory Compliance Virgin Galactic Holdings IncEngineering Manager, FAA Regulatory ComplianceTustin, CA$99,498–$151,719 / yearRequires a minimum of 6 years' experience in aerospace or similar industry having technical regulatory requirements with a bachelor's degree in an engineering or technical discipline (STEM required); or 4 years of experience with a Master's Degree; and a minimum of 4 or more years of management and/or leadership experience. We are seeking an experienced aerospace Engineering Manager, FAA Regulatory Compliance to lead the critical activities that ensure regulatory compliance related to our vehicles and mission operations.
Principle Regulatory Affairs Strategy Associate Aequor Technologies LLCPrinciple Regulatory Affairs Strategy AssociateLake Forest, CAThe Principle Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product registration and facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. Expectations / Responsibilities: A self-starter, assertive leader who will be accountable for the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.
Sr MDR Specialist Masimo CorpSr MDR SpecialistIrvine, CA$86,000–$108,000 / yearMDR Specialist partners cross-functionally with Regulatory Affairs, Clinical, Quality, Engineering, and Manufacturing teams to ensure timely and accurate adverse event reporting, support audit readiness, identify compliance risks, and drive continuous improvement initiatives related to complaint handling and global vigilance processes. Respond to regulatory authority inquiries, requests for additional information, and follow-up communications related to MDRs, vigilance reports, adverse events, field actions, and post-market surveillance activities.
Manager II, Regulatory Affairs Tarsus Pharmaceuticals IncManager II, Regulatory AffairsIrvine, CARemote$120,000–$168,000 / yearLet's talk about some of the key responsibilities of the role: Assist in performing and managing the initial part of the workflow (Initial QC, routing, scheduling meetings, etc.) in the Veeva system for material review and approval of the materials submitted from the assigned business units. A Few Other Details Worth Mentioning: The position can be either Remote or based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals.
Regulatory Affairs Coordinator University of California, IrvineRegulatory Affairs CoordinatorOrange, Californiali>Proven organizational skills and attention to detail; ability to multi-task, prioritize a complex and dynamic workload, meet rigid deadlines despite interruptions, frequent workload changes and competing demands, and achieve high productivity/quality within short time frames; skill in working independently, taking initiative and following through on assignments and ability to work as part of a team. *Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.