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 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.
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.
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 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.
Regulatory Affairs Manager - Cardiovascular Surgery Medtronic PlcRegulatory Affairs Manager - Cardiovascular SurgeryCAp>If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Manager II, Regulatory Affairs the Tarsanet Internal Career CenterManager II, Regulatory AffairsIrvine, CaliforniaRemoteFor more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot. 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.
Senior Manager Regulatory Affairs US Advertising and Promotion - US Specialty AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - US SpecialtyIrvine, CAli>Oversees 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. US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html.
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.
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.
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.
Manager Regulatory Affairs Device-Combination Products AbbVie IncManager Regulatory Affairs Device-Combination ProductsIrvine, CAli>Represents 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.
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.
CMS Chemical Regulatory Manager RED Digital CinemaCMS Chemical Regulatory ManagerFoothill Ranch, CaliforniaThis role oversees regulatory strategy, product compliance, hazard communication, and chemical risk management to ensure adherence to applicable local, regional, and international regulations. The position partners cross-functionally with R&D, Quality, Supply Chain, and Manufacturing to support product development, market access, and ongoing regulatory compliance.
Senior Manager, Global Regulatory Affairs, CMC Jazz Pharmaceuticals PlcSenior Manager, Global Regulatory Affairs, CMCCARemote$140,000–$210,000 / yearThe successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. Participate and support as an active member of a multi-disciplinary team to establish Regulatory CMC strategies for commercial products, late- and early-stage development programs, under the supervision of GRA-CMC leadership.
Regulatory Affairs Manager Katalyst Healthcares & Life SciencesRegulatory Affairs ManagerIrvine, CAdiv> Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
CMS Chemical Regulatory Manager Red Digital Cinema, Inc.CMS Chemical Regulatory ManagerFoothill Ranch, CA$105,000–$120,000 / yearPart timeThis role oversees regulatory strategy, product compliance, hazard communication, and chemical risk management to ensure adherence to applicable local, regional, and international regulations. The position partners cross-functionally with R&D, Quality, Supply Chain, and Manufacturing to support product development, market access, and ongoing regulatory compliance.
Manager Regulatory Affairs-Chemistry Manufacturing & Controls CMC AbbVie IncManager Regulatory Affairs-Chemistry Manufacturing & Controls CMCIrvine, CAli>Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions and stays abreast of regulatory procedures and changes in the external regulatory environment. US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html.
Manager, Regulatory Affairs iRhythm Holdings IncManager, Regulatory AffairsOrange County, CARemote$127,000–$165,000 / yearFor more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121. Lead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products.
Regulatory Affairs Manager Karwell TechnologiesRegulatory Affairs ManagerIrvine, CAdiv> Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
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.
Manager, Regulatory V 26-00077 Alura Workforce SolutionsManager, Regulatory V 26-00077Pomona, CAThis role will focus on evaluating emerging grid technologies and architecture through financial and economic analysis, supporting investment decisions, and ensuring alignment with regulatory requirements. The position will play a key role in developing cost-benefit analyses, financial models, and business cases to support strategic planning and grid modernization initiatives.
Sr. Program Manager Regulatory Affairs - Risk Management - FT Days University of CaliforniaSr. Program Manager Regulatory Affairs - Risk Management - FT DaysIrvine, CA2025 University of California, Irvine, UCI Health, and UC Regents. Sign-up to be notified of hiring events, newly posted job opportunities, and much more.
Regulatory Affairs & Quality Assurance Manager University of CaliforniaRegulatory Affairs & Quality Assurance ManagerIrvine, CAp>2025 University of California, Irvine, UCI Health, and UC Regents. Sign-up to be notified of hiring events, newly posted job opportunities, and much more.
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.
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.
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.
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.
NewRegulatory 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.
Senior Associate Regulatory Affairs Submission Management AbbVie IncSenior Associate Regulatory Affairs Submission ManagementIrvine, CAWith input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. Responsibilities: Manages medium to high impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
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. Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs.
Utility Regulatory Affairs Senior Advisor Edison InternationalUtility Regulatory Affairs Senior AdvisorRosemead, CAIn this job, you'll be developing and advocating the Company's positions associated with wholesale generation and energy storage interconnections to SCE's distribution system, including managing the development of revisions to SCE's wholesale distribution access tariff. Become a Utility Regulatory Affairs Senior Advisor at Southern California Edison (SCE) and help meet our goals of interconnecting clean energy resources to SCE's grid.
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.
NewAssistant Regulatory Affairs Coordinator University of California, IrvineAssistant Regulatory Affairs CoordinatorOrange, California$26.60–$43.82 / hourli>Demonstrated 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.
Regulatory Affairs Specialist Nihon KohdenRegulatory 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. Prepare regulatory submissions for new products and product changes as required to ensure timely approval for clinical studies and product market release.
NewUtility Regulatory Affairs Senior Advisor Southern California EdisonUtility Regulatory Affairs Senior AdvisorRosemead, CAIn this job, you'll be developing and advocating the Company's positions associated with wholesale generation and energy storage interconnections to SCE's distribution system, including managing the development of revisions to SCE's wholesale distribution access tariff. Become a Utility Regulatory Affairs Senior Advisor at Southern California Edison (SCE) and help meet our goals of interconnecting clean energy resources to SCE's grid.
Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs Dendreon CorporationVice President, Regulatory Affairs, Clinical Operations & Medical AffairsSeal Beach, CaliforniaThis executive role ensures alignment across clinical development, regulatory strategy, scientific communications, and product lifecycle management to support the successful development, approval, and commercialization of the company's products. Develop and maintain strategic relationships with physicians, investigators, Key Opinion Leaders (KOLs), healthcare providers, and scientific experts to support clinical development, evidence generation, product adoption, and medical education initiatives.
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.
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.
Director of Licensing & Regulatory Affairs (SMR / MMR Programs) BaRupOn LLCDirector of Licensing & Regulatory Affairs (SMR / MMR Programs)Irvine, CAp>BaRupOn LLC is seeking a highly experienced Director of Licensing & Regulatory Affairs to lead all regulatory strategy, licensing execution, and compliance activities for its Small Modular Reactor (SMR) and Micro Modular Reactor (MMR) programs in the United States. The ideal candidate brings deep, direct NRC engagement experience, a thorough command of U.S. nuclear regulatory frameworks, and the leadership ability to build and manage a high-performing regulatory team in a fast-moving, mission-driven environment.
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.
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.
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.
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.
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. 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.
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.
Regulatory Affairs Specialist, Sr. Glidewell DentalRegulatory Affairs Specialist, Sr.Irvine, CaliforniaIf you excel at interpreting regulations, managing complex documentation, and guiding teams through compliance requirements, this is an opportunity to make a meaningful impact in a fast‑moving, innovative environment.Essential Functions:Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Knowledge and Abilities:Proficient knowledge of general office procedures.
Regulatory Affairs Director VitalConnect IncRegulatory Affairs DirectorCA$150,000–$175,000 / yearul>Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including device submissions in USA, Europe and other countries. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports.
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.