Quality Assurance Regulatory Affairs Manager

3 weeks ago


California, United States Connect Life Science Full time

Quality Assurance Regulatory Affairs Manager This range is provided by Connect Life Science. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $100.00/hr - $130.00/hr Direct message the job poster from Connect Life Science Quality, Regulatory & R&D Staffing Expert | Contract & Permanent Hires | Building World Class Life Sciences Teams. Quality & Regulatory Affairs Consultant - No C2C & Work Authorization required Bay Area, CA - Hybrid Working Class III Medical Device 12 month contract, full time hours Competitive hourly rate An innovative MedTech company based in the Bay Area, CA specializing in Class III implantable device development are looking to hire a contractor for a 12-month contract to support with Quality and Regulatory activities across their key product and Quality System. You will play a key role in ensuring compliance with the regulatory requirements and quality standards of their devices. Your expertise in regulations relating to class III medical devices and quality management systems will drive regulatory strategy and you'll support regulatory submissions (FDA and EU MDR). Responsibilities: Support implementation of QMS upgrades and changes Lead / support PMA activities Provide guidance and support to cross‑functional teams in the interpretation and implementation of regulatory requirements, standards, and guidelines (e.g., ISO 13485 and FDA). Assist in the development of risk management strategies. Work with R&D to ensure regulatory compliance is integrated into the development life cycle. Prepare and review regulatory submissions, technical files, and design dossiers. You: Degree in a relevant field (Engineering, Life Science, Regulatory Affairs etc.) Solid experience of medical device QA/RA requirements Familiarity with medical device development life cycle methodologies, risk management, and QMS. Strong knowledge of FDA regulation and ISO 13485. Experienced Contractor/Consultant Seniority level: Mid‑Senior level Employment type: Contract Job function: Quality Assurance Industries: Medical Equipment Manufacturing #J-18808-Ljbffr



  • California, United States ALKU Full time

    Associate Director, Regulatory Affairs Background: This is a global regulatory lead position responsible for leading and supporting multiple early phase global regulatory projects, and ensuring compliance with all relevant regulatory requirements and guidelines. This position will report to the Executive Director, Regulatory Affairs and collaborate with...


  • California, United States International Executive Service Corps Full time

    Regulatory Affairs Manager - Electric (90.25) Location SAN DIMAS, CA (Headquarters/General Office) Job Code 90.25 Pay range $125,517 - $233,055 AnnuallyGolden State Water Company is one of the largest investor-owned water utilities in the United States. We deliver quality, reliable water to more than 1 million people in over 80 communities throughout...


  • California, United States AbCellera Full time

    Base pay range $278,740.00/yr - $348,425.00/yr From target to the clinic. AbCellera’s platform integrates biology, computation, and engineering to develop impactful antibody-based medicines. We’re scientists, engineers, and business professionals who work together to turn scientific insights into breakthrough medicines. We pursue truth and scientific...


  • California, United States AbCellera Full time

    1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. From target to the clinic. AbCellera’s platform integrates biology, computation, and engineering to develop impactful antibody-based medicines. We’re scientists, engineers, and business professionals who work together to turn scientific insights into...


  • California, United States Middle River Power Full time

    Western Regulatory and Market Affairs Manager Middle River Power (“MRP”) seeks a Western Regulatory and Market Affairs Manager focused on western markets, with an emphasis on California. Working with MRP’s commercial, development and strategy teams, this person will analyze, report on, and advocate for regulatory and market policies to help shape and...


  • California, United States Cates Consulting Full time

    Director/Senior Director, Clinical Quality Assurance This range is provided by Cates Consulting. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range $200,000.00/yr - $245,000.00/yr Additional compensation types Annual Bonus and Stock options Direct message the job poster from Cates Consulting...


  • California, United States Brookfield Renewable U.S. Full time

    Director, Regulatory Affairs - West Work Location: West (Remote) This position presents an opportunity to play a key role in a growth‑oriented business that is a global leader in the renewable energy industry. It is ideally suited to a knowledgeable, career‑oriented individual seeking a challenging growth opportunity in renewable power. The role reports...


  • California, United States Metric Bio Full time

    Head of Quality Assurance (Director level) Metric Bio are partnered with a leader in the Bio-Analytical CRO space as we search for a Head of Quality Assurance (Director level) to develop and manage the continuous improvement of quality systems. Here, you'll leverage your 10+ years in the space and solid understanding of GLP in our bio-analytical lab in...


  • California, United States Annexon Full time

    At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it...


  • California, United States Sonova International Full time

    Location: Valencia, CA (Hybrid) Senior Director Global Clinical Affairs & Medical Affairs The Sr. Director Global Clinical and Medical Affairs is responsible for leading the planning and execution of clinical research and medical affairs programs to support regulatory approval, market access and product life-cycle initiatives for Advanced Bionics portfolio...