NewGlobal Logistics Specialist JobotGlobal Logistics SpecialistSan Clemente, CA$75,000–$90,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. The successful candidate will work closely with logistics service providers and transportation partners to manage day-to-day operations while also contributing to strategic initiatives such as carrier evaluations, contract discussions, freight optimization, and cost reduction efforts.
NewGlobal Transportation & Logistics Specialist JobotGlobal Transportation & Logistics SpecialistSan Clemente, CA$70,000–$90,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. This is a hands-on, high-impact individual contributor role where you’ll manage logistics partners, optimize freight spend, and play a key role in improving global transportation processes.
NewGlobal Freight Management Specialist JobotGlobal Freight Management SpecialistSan Clemente, CA$70,000–$90,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. This role is critical in ensuring efficient, compliant, and cost-effective movement of goods while partnering cross-functionally with internal teams and external logistics providers.
NewProject Billing Specialist JobotProject Billing SpecialistAnaheim, CA$80,000–$90,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. The ideal candidate will have a strong background in job cost, Construction Accounting, Project Accounting, T&M, Time & Material, time and material, and experience with Sage, Vista Viewpoint, viewpoint, job costing, AIA billing, and AIA invoicing.
NewDocumentation Specialist-In Office JobotDocumentation Specialist-In OfficeAnaheim, CA$22–$25 / hourInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. The Quality Support Coordinator Provides administrative and operational support for quality‑related processes, including performance tracking, reporting, and coordination of internal and external feedback.
NewEHS Specialist JobotEHS SpecialistGarden Grove, CA$75,000–$105,000 / yearThe team is looking for candidates who are skilled in conducting safety training, hazard analysis, incident investigations, hazardous waste management, environmental reporting, and maintaining compliance documentation, including SDS records, permits, and prevention plans. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
NewGrievance and Appeals Nurse Specialist (LVN or RN) Kinetic Personnel GroupGrievance and Appeals Nurse Specialist (LVN or RN)Orange, CA$43–$65 / hourTemporaryUtilize computer and appropriate software (e.g., Microsoft Office: Excel, Outlook, PowerPoint, Word) and job-specific applications/systems to produce correspondence, charts, spreadsheets and/or other information applicable to the position assignment. A permanent position does include excellent CalPERS pension, 401a (4% contribution) and excellent government benefits and Holiday/PTO schedule.
NewGrievance Resolution Specialist Kinetic Personnel GroupGrievance Resolution SpecialistOrange, CATemporaryGathers pertinent information regarding the grievances and appeals received, including, but not limited to, member or provider concerns, supporting information related to initial decision-making, new information supporting the grievance or appeal, or supplemental information required to evaluate grievances and appeals within regulatory requirements. The Grievance Resolution Specialist coordinates the Grievance and Appeal resolution process, responds to verbal and written Grievances and Appeals from members and/or providers relating to member eligibility and benefits, contract administration, claims processing, utilization management decisions, and pharmacy and vision decisions.
NewGovernment Audit Recovery Specialist IconmaGovernment Audit Recovery SpecialistCosta Mesa, CA$27–$32 / hourResponsible for responding to correspondence from Government Agencies related to Recovery Audit Contractor (RAC), Medicare Administrative Contractor (MAC), Targeted Provider Education (TPE), Comprehensive Error Rate Testing (CERT), Office of Inspector General (OIG), Quality Improvement Organizations (QIO) and other Medicaid, Medi-Cal regulatory auditing body for pre and post payment audits. Experience working on government, Recovery Audit Contractor (RAC), Medicare Administrative Contractor (MAC), Targeted Provider Education (TPE), Comprehensive Error Rate Testing (CERT), Office of Inspector General (OIG), and other Medicaid, Medi-Cal and other regulatory audits.
NewIncident Response Specialist ECLAROIncident Response SpecialistFountain Valley, CAThis role involves managing and responding to security incidents, performing detailed investigations into breaches, and developing strategies to prevent future infractions. The ideal consultant is a critical thinker with a deep understanding of cyber threats and vulnerabilities, and a strong knowledge of IT systems and security infrastructure.
Brass Instrument Repair Specialist Music & ArtsBrass Instrument Repair SpecialistAnaheim, CA$20–$30We strive to create lifelong musicians and make a difference in the world by enabling musicians and non-musicians alike to experience the almost indescribable happiness that comes from playing an instrument. Based in Frederick, MD, Music & Arts is now part of the Guitar Center enterprise and comprises 225+ retail stores, 200+ educational representatives, and 250+ affiliate locations.
NewM&A Tax Specialist Diedre Moire Corp.M&A Tax SpecialistLos Angeles, CA$300,000–$400,000 / yearFull timeBuyer and seller allocation of purchase price as, for example, an asset or 338 transaction; IRC Section 1060; GAAP treatment related to structuring and purchase price allocation; Section 1231 gains such as: goodwill, land, and other assets with fair market values higher than original tax cost; Section 197 issues such as: short-lived assets including machinery and equipment, inventory, prepaid expenses, etc. • Post-Transaction Filing Elections and Requirement such as: Adjusting or selecting different tax elections and accounting periods and methods; Year-end conformity with affiliated companies' year-ends and "short-period" returns; Responsibility for the pre- and post-acquisition income tax, payroll tax, property tax and other filings.
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.
NewRegulatory Affairs Specialist I City of HopeRegulatory Affairs Specialist ICAUnder supervision, you will assist with regulatory submission activities, lifecycle management of assigned INDs, and review of investigator regulatory files to support compliance with applicable institutional requirements, FDA regulations and guidance, and ICH and Good Clinical Practice (GCP) guidelines. Your qualifications should include: Bachelor''s Degree in scientific discipline, regulatory affairs, or a related field with a minimum of 3-5 years of experience or a Masters/PhD in scientific discipline, regulatory affairs, or a related field with a minimum of 0-2 years of experience.
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.
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.
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).
Associate Labeling Specialist – Regulatory Affairs Applied MedicalAssociate Labeling Specialist – Regulatory AffairsRancho Santa Margarita, California$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.
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.
NewSr. Regulatory Affairs Specialist - Ad/Promo Prolacta BioscienceSr. Regulatory Affairs Specialist - Ad/PromoCity of Industry, California$112,000–$125,000A 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. Experience coordinating cross-functional reviews, resolving comments, maintaining trackers, preparing status updates, and supporting timely completion of review, approval, submission, and record-retention activities.
Regulatory Affairs and Quality Assurance Specialist SprintRay IncRegulatory Affairs and Quality Assurance SpecialistHuntington Beach, CA$90,000–$120,000 / yearTo 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 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 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.
Sr. Specialist, Regulatory Affairs Metagenics LLCSr. Specialist, Regulatory AffairsAliso Viejo, CAIndustry 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.
Regulatory Affairs Specialist Broadata CommunicationsRegulatory Affairs SpecialistTORRANCE, CAFull timeThis 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.
Sr. Specialist, Regulatory Affairs MetagenicsSr. Specialist, Regulatory AffairsAliso Viejo, CaliforniaMonitors 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.
Regulatory Affairs Specialist (FDA/Medical Device) Staffmark Group LlcRegulatory Affairs Specialist (FDA/Medical Device)Torrance, CAAn 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 Submission Management: Meticulously compile and organize technical documentation for 510(k), PMA, De Novo, and Annual Reports, ensuring zero errors in compliance.
Regulatory Affairs and Quality Assurance Specialist SprintRayRegulatory Affairs and Quality Assurance SpecialistHuntington Beach, California$90,000–$120,000Without 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.
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 LifesciencesSpecialist, Regulatory Affairs SurgicalIrvine, California$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. 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.
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.
NewSenior Specialist, Regulatory Affairs (THV) JenaValve TechnologySenior Specialist, Regulatory Affairs (THV)Irvine, CAOrganizational & 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.
Asset and Wealth Management External Audit - Regulatory Reporting Specialist - Director PricewaterhouseCoopers LLPAsset and Wealth Management External Audit - Regulatory Reporting Specialist - DirectorCA$134,000–$348,500 / yearAs an Asset and Wealth Management External Audit - Regulatory Reporting Specialist - Director, you will play a pivotal role in guiding clients through complex regulatory landscapes, enhancing their internal controls, and mitigating risks effectively. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy.
NewPermitting & Regulatory Compliance Specialist II Core States GroupPermitting & Regulatory Compliance Specialist IILong Beach, CARemoteHEALTHCARE - Competitive health benefits including HSA with employer contribution, life insurance options, and supplemental coverage options, giving you the flexibility to select the coverage that best fits your needs and lifestyle. Core States Group designs, builds, and manages programs and projects across North America and has been recognized on top lists throughout the architecture, engineering, and construction (A/E/C) industry.
Clinical Regulatory Specialist RadNet Los AngelesClinical Regulatory SpecialistAnaheim, California$80,000–$97,000 / yearFull timeMonitors external sites and imaging centers for accuracy of data submitted by comparison with source documents; monitors compliance with execution of protocol requirements by comparison of source documents with protocol document; monitors completeness and accuracy of AE reporting; and monitors compliance with regulatory requirements. When you join us as a Clinical Regulatory Specialist you will be joining a dedicated team of professionals who deliver quality, value, and access in the 21st century and align all stakeholders- patients, providers, payors, and regulators to achieve the best clinical outcomes.
Regulatory Compliance Specialist The Related Companies LPRegulatory Compliance SpecialistCARemote$75,000–$90,000 / yearReview initial qualifying files for accuracy and program compliance and submit to third-party reviewers; Track qualification status and works with the Director of Compliance to provide clear and accurate reporting on lease-ups, move-ins, etc. You will be responsible for ensuring Related Affordable is operating in compliance with all affordable housing program guidelines (LIHTC, PBS8, PBV, RAD, etc.), regulatory agreements, and company policies and procedures.
Clinical Regulatory Specialist RadNet IncClinical Regulatory SpecialistAnaheim, CA$80,000–$97,000 / yearMonitors external sites and imaging centers for accuracy of data submitted by comparison with source documents; monitors compliance with execution of protocol requirements by comparison of source documents with protocol document; monitors completeness and accuracy of AE reporting; and monitors compliance with regulatory requirements. When you join us as a Clinical Regulatory Specialist you will be joining a dedicated team of professionals who deliver quality, value, and access in the 21st century and align all stakeholders- patients, providers, payors, and regulators to achieve the best clinical outcomes.
Regulatory Affaris Specialist - Temporary Bio-Rad Laboratories IncRegulatory Affaris Specialist - TemporaryIrvine, CA$45–$50 / hourOther miscellaneous activities will include updating the technical file tracking log, notifying and tracking RA Regional notifications of labeling changes, and notifying the RA SAP restriction coordinator when specific product lots need to be restricted to prevent distribution of the product in specific areas of the world. Each technical file must include the latest version of the required technical reports, validations, test reports and other documents listed in the technical file table of contents which are an integral part of the technical file.
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.
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).
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 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 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.
NewSenior Manager, Regulatory Affairs Strategy AlconSenior 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. 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.
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.
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 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 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 Manager I Alcon ResearchRegulatory Affairs Manager ILake Forest, CaliforniaThe 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).