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Keywords: Director of Quality and Regulatory Affairs, Location: California

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Director of Quality and Regulatory Affairs

Position Summary The Director of Quality and Regulatory Affairs will report directly to the CEO and be responsible... Requirements (Must-Have) 7+ years of experience in Quality Assurance and Regulatory Affairs within the medical device industry...

Company: SleepRes, Inc.
Location: California
Posted Date: 03 Dec 2025

Associate Director, Regulatory Affairs CMC

to work in our office three days per week on average. Position Summary The Associate Director, Regulatory CMC... to conduct global drug development and commercial activities. Primary Responsibilities Supports CMC regulatory affairs...

Posted Date: 17 Dec 2025

Senior Director/ Director, CMC Regulatory Affairs

, we are currently hiring a Director, CMC Regulatory Affairs, to join our Technical Operations team. This position is responsible... involves close collaboration with cross-functional teams including regulatory affairs, regulatory operations, quality, CMC...

Posted Date: 14 Dec 2025

Director/Sr. Director Regulatory Affairs

future of biopharma. What You'll Do The Director/Senior Director of Regulatory Affairs will lead global regulatory... correspondence, and coordinating timely responses to inquiries Act as the lead regulatory affairs representative in the planning...

Company: BridgeBio
Location: California
Posted Date: 12 Dec 2025

Sr Manager/ Associate Director Regulatory Affairs - US Lead

cancers. Our Client is seeking a dynamic and experienced Sr Manager / Associate Director of Regulatory Affairs. The role... is responsible for ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project...

Company: NWRPros
Location: Palo Alto, CA
Posted Date: 11 Dec 2025

Director, Regulatory Affairs (Office based - 3x/week)

, and long-term growth. Job Description The Director, Regulatory Affairs is responsible for leading the development..., and ensures compliance with evolving regulatory requirements. Additionally, the Director serves as the US/EU regulatory lead...

Company: Zai Lab (US) LLC
Location: San Francisco, CA
Posted Date: 23 Nov 2025
Salary: $221000 - 246000 per year

Associate Director Regulatory Affairs

of Regulatory Affairs will provide regulatory support for medical device systems within infusion technologies. The role includes... for regulatory affairs submissions, handling existing product registrations including variations and renewals, interacting...

Company: BD
Location: San Diego, CA
Posted Date: 21 Nov 2025

Director, Regulatory Affairs

Affairs is responsible for developing and implementing regulatory strategies with the Senior Director, Regulatory Management... in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Director of Regulatory...

Company: BD
Location: San Diego, CA
Posted Date: 12 Nov 2025

Regulatory Affairs Director

for today’s connected consumers. Position Summary Truvian is seeking an experienced and hands-on Regulatory Affairs Director to lead... diagnostic testing. This position is onsite and reports to the Head of Quality & Regulatory. This is a high-impact, hands...

Company: Truvian Sciences
Location: San Diego, CA
Posted Date: 15 Oct 2025
Salary: $168000 - 186000 per year

Director, Regulatory Affairs - Gene Therapy

, for each other, and for the future of science, we're in. Are you? About the Role: The Director, Regulatory Affairs will serve as the regulatory... central messaging, preparation, and submission of high quality, regulatory complaint regulatory dossiers Direct hands...

Posted Date: 03 Oct 2025

Director_Sr. Director, Regulatory Affairs

regulatory affairs leader to drive our mission of transforming cancer care through targeted radiotherapy. The ideal candidate... in regulatory affairs (radiopharmaceuticals is a plus). This role demands a proactive, collaborative professional who thrives...

Posted Date: 26 Sep 2025

Director, US Medical Affairs, Patient Access and Quality of Care (PAQ) – Portfolio Strategy

, CA headquarters, or Parsippany, NJ office. Director, US Medical Affairs, Patient Access and Quality of Care (PAQ) – Portfolio... care of patients with life-threatening diseases. We have an exciting opportunity within US Medical Affairs for a Director...

Company: Gilead
Location: Foster City, CA
Posted Date: 29 Oct 2025

Director, Legal (Regulatory and Quality Counsel)

, you will do more and become more than you ever thought possible. Position Summary The Director, Legal (Regulatory and Quality Counsel) will serve... will operate in a highly matrixed global environment, collaborating across Regulatory Affairs, Quality, Medical Affairs, Sales...

Company: Illumina
Location: San Diego, CA
Posted Date: 11 Dec 2025

Senior Manager, Global Regulatory Affairs Strategy

Affairs Strategy, reporting to the Senior Director, Global Regulatory Affairs Strategy, you will provide regulatory strategy... Under the supervision of the Senior Director, Regulatory Affairs, contribute to planning and execution of regulatory...

Company: Olema Oncology
Location: San Francisco, CA
Posted Date: 04 Dec 2025
Salary: $176000 - 188000 per year

Regulatory Affairs Principal

to complicated assay, instrument, software projects and/or system projects. This position reports to the Director Regulatory... Affairs, NPD and is part of the Regulatory Affairs New Product Development department located in Sunnyvale, CA. Remote work...

Company: Danaher
Location: Sunnyvale, CA
Posted Date: 21 Nov 2025
Salary: $135000 - 190000 per year

Regulatory Affairs Manager

for the regulatory affairs department that comply with internal, domestic, and international quality regulations.... Responsibilities: The Regulatory Affairs Manager will report to the Senior Director of Global Regulatory Affairs (located in the EU...

Posted Date: 14 Nov 2025

Senior Specialist, Regulatory Affairs

, and international regulatory agencies develop regulations. Provide back up to the Regulatory Affairs Director as needed. Responsible...Job Category: Quality Assurance Job Description: Provide regulatory guidance in product design, clinical studies...

Posted Date: 18 Oct 2025
Salary: $90000 - 130000 per year

Scientific Director, Medical Affairs

on , , , , and . Job Description The Scientific Director, US Medical Affairs will provide strategic scientific leadership and expertise to advance the... with both TA and Commercial Strategies. Ensure compliance with regulatory and ethical standards in all medical affairs activities...

Company: AbbVie
Location: Irvine, CA
Posted Date: 19 Dec 2025

Scientific Director, Medical Affairs

on , , , , and . Job Description The Scientific Director, US Medical Affairs will provide strategic scientific leadership and expertise to advance the... with both TA and Commercial Strategies. Ensure compliance with regulatory and ethical standards in all medical affairs activities...

Company: AbbVie
Location: Irvine, CA
Posted Date: 19 Dec 2025

US Medical Senior Director, Medical Affairs Evidence Generation

Collaboration and Compliance Partner across Kite Medical Affairs, Clinical Development, Translational Medicine, Regulatory Affairs... Senior Director, MA Evidence Generation at Kite Pharma, a Gilead Company, will provide scientific and strategic leadership...

Company: Kite Pharma
Location: Santa Monica, CA
Posted Date: 12 Dec 2025