Regulatory Affairs Director

5 days ago


San Jose, California, United States Stryker Full time

We are seeking a highly skilled Regulatory Affairs Director to join our team at Stryker. As a key strategist, you will be responsible for developing and implementing regulatory strategies for our Endoscopy business unit.

The ideal candidate will have a strong understanding of regulatory requirements, including ISO, FDA, and International standards. You will work closely with business unit leadership, Marketing, R&D, Clinical, and Quality teams to develop and advise on product positioning, product entry and exit strategies, and other regulatory matters.

This role requires a hybrid work schedule of three days per week in our San Jose, CA office. Relocation support is available for the right candidate.

Key Responsibilities:

  • Develop and implement regulatory strategies for the Endoscopy business unit
  • Collaborate with cross-functional teams to develop and advise on product positioning, product entry and exit strategies, and other regulatory matters
  • Stay up-to-date on regulatory requirements, including ISO, FDA, and International standards
  • Manage negotiations with regulatory authorities on complex issues throughout the product lifecycle
  • Lead efforts to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs

Requirements:

  • Bachelor's degree in engineering or other relevant field of study
  • Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International standards
  • Demonstrated expertise in regulatory systems in a regulated environment
  • Demonstrated project management skills
  • Demonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targets

Financial Benefits:

Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine that help improve patient and healthcare outcomes.

Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

Stryker is an EO employer – M/F/Veteran/Disability.



  • San Jose, California, United States Stryker Full time

    Job Title: Director, Regulatory AffairsStryker Corporation is seeking a highly skilled and experienced Director, Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with international standards and government regulations.Key...


  • San Jose, California, United States Stryker Full time

    Regulatory Affairs Director Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at Stryker. As a key strategist, you will be responsible for developing and implementing regulatory strategies for our Endoscopy business unit.Key Responsibilities:Develop and advise on product positioning, product entry and exit strategies,...


  • San Jose, California, United States Stryker Full time

    Job Summary:The Director, Regulatory Affairs is a key strategist responsible for developing regulatory strategy for the Endoscopy business unit and delivering Stryker's best-in-class Visualization products to market in the United States, Canada, and Europe.Through close partnership with business unit leadership, Marketing, R&D, Clinical, and Quality teams,...


  • South San Francisco, California, United States BioSpace, Inc. Full time

    Job Title: Regulatory Affairs DirectorAlumis Inc. is seeking an exceptional Regulatory Affairs Director to provide leadership and support to global regulatory activities. The ideal candidate will have a strong background in regulatory affairs, with experience in developing and implementing regulatory strategies to facilitate the progress of assigned...


  • South San Francisco, California, United States BioSpace, Inc. Full time

    Job Title: Regulatory Affairs DirectorAlumis Inc. is seeking an exceptional Regulatory Affairs Director to provide leadership and support to global regulatory activities. The ideal candidate will have a strong background in drug development, regulatory affairs, and immunology or rare disease/orphan drug development experience.Key Responsibilities:Develop and...


  • San Diego, California, United States CorDx Full time

    Job Title: Associate Director of Regulatory AffairsCorDx is a leading biotech organization dedicated to delivering innovative medical device solutions. We are seeking an experienced Associate Director of Regulatory Affairs to lead our regulatory submissions and ensure compliance with applicable regulations.Key Responsibilities:Prepare and submit regulatory...


  • South San Francisco, California, United States Synectics Full time

    Job Title: Regulatory Affairs Associate Director/DirectorJoin Synectics, a leading pharmaceutical company, as a Regulatory Affairs Associate Director/Director and take on a challenging role in shaping the future of oncology drug development.Responsibilities:Develop and implement global regulatory strategies to support the development of multiple oncology...


  • San Diego, California, United States Gossamer Bio Full time

    Job SummaryWe are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at Gossamer Bio. As a Director / Senior Director, CMC Regulatory Affairs, you will be responsible for developing and executing innovative CMC regulatory strategies in support of the global development and commercialization of a drug/device combination...


  • South San Francisco, California, United States BioSpace, Inc. Full time

    Regulatory Affairs DirectorWe are seeking a highly motivated individual to provide leadership and support to global regulatory activities to achieve our strategic vision in obtaining worldwide approvals to market our products.The individual will represent Regulatory Affairs and work closely with cross-functional teams and development partners while managing...


  • San Diego, California, United States Codera Full time

    Job Title: Director, Regulatory AffairsCodera is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. We are seeking a highly skilled Director, Regulatory Affairs to support the development and execution of domestic and international regulatory strategy for Codera.Key...


  • San Diego, California, United States Codera Full time

    Job Title: Director, Regulatory AffairsCodera is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. We are seeking a highly skilled Director, Regulatory Affairs to support the development and execution of domestic and international regulatory strategy for Codera.Key...


  • San Diego, California, United States CorDx Full time

    Job OverviewCorDx is a leading biotech organization dedicated to delivering innovative medical device solutions. We are seeking an experienced Associate Director of Regulatory Affairs to lead our regulatory submissions and ensure compliance with applicable regulations.This role will play a crucial part in the successful approval and launch of our medical...


  • San Diego, California, United States BioSpace, Inc. Full time

    Job Title: Associate Director Regulatory AffairsAt BioSpace, Inc., we are seeking an experienced Associate Director Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will be responsible for establishing regulatory strategies and plans, communicating with internal stakeholders, and ensuring compliance with...

  • Executive Director

    1 week ago


    San Francisco, California, United States NextEra Energy , Inc. Full time

    Job SummaryNextEra Energy, Inc. is seeking an Executive Director - Regulatory Affairs to lead our regulatory affairs efforts in the West Region. This role will be responsible for overseeing all regulatory affairs activities, including policy coordination, stakeholder engagement, and regulatory proceedings.Key Responsibilities:Develop and implement regulatory...


  • San Francisco, California, United States KMR Search Group Full time

    Job Title: Senior Director, Regulatory AffairsJob Description Job Summary:This role will support global CMC regulatory activities related to investigational/commercial large molecule biologic products. The Senior Director, Regulatory Affairs will serve as a strategic business partner in providing regulatory CMC guidance to various development teams and for...


  • South San Francisco, California, United States Structure Therapeutics Full time

    Job Title: Senior Director, Regulatory AffairsStructure Therapeutics is seeking a seasoned Senior Director, Regulatory Affairs to lead the development and execution of regulatory strategies and operations for our products. As a key member of our leadership team, you will be responsible for guiding our products through development, approval, and post-approval...


  • San Francisco, California, United States KMR Search Group Full time

    Job Title: Senior Director, Regulatory AffairsJob DescriptionJob Summary:This position will support global CMC regulatory activities related to investigational/commercial large molecule biologic products. The successful candidate will serve as a strategic business partner in providing regulatory CMC guidance to various development teams and for preparation...


  • South San Francisco, California, United States Abdera Therapeutics Full time

    Job Title: Director/Senior Director RegulatoryAbout Abdera TherapeuticsAbdera Therapeutics is a precision oncology company developing next-generation targeted radiation therapies. We are a rapidly growing company seeking key new team members who thrive at the cutting-edge of innovation.Job SummaryWe are looking for a highly experienced and skilled...


  • South San Francisco, California, United States Abdera Therapeutics Full time

    Job Title: Director/Senior Director RegulatoryAbout Abdera TherapeuticsAbdera Therapeutics is a precision oncology company developing next-generation targeted radiation therapies. We are a rapidly growing company seeking key new team members who thrive at the cutting-edge of innovation.Job SummaryWe are looking for a highly experienced and skilled...


  • South San Francisco, California, United States Abdera Therapeutics Full time

    About the RoleAbdera Therapeutics is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory strategies and contingencies for assigned programs, in order to support Abdera's development objectives.Key ResponsibilitiesLead and prepare FDA...