Regulatory Affairs Director
5 days ago
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.
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