Senior Regulatory Affairs Specialist
4 days ago
We are seeking a highly skilled Senior Staff Regulatory Affairs Specialist to join our Joint Replacement Division based in Weston, FL or Mahwah, NJ.
About the RoleThis is a key position that will support Stryker's Joint Replacement Robotics and Digital medical device hardware and software new product development and sustaining for both US and OUS Global Regulatory release by contributing to the development of regulatory strategy.
Key Responsibilities- Evaluate the regulatory environment and provide internal advice throughout the product lifecycle to ensure product compliance.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
- Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
- Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.
- Identify the need for new regulatory procedures, SOPs, and participate in development and implementation.
- Provide regulatory input and technical guidance on global regulatory requirements to product development teams.
- Assess the acceptability of quality, preclinical, and clinical documents for submission filing to comply with applicable regulations.
- Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
- Bachelor's Degree (B.S or B.A) in Engineering, Science is required.
- 7+ years of experience in an FDA regulated industry required, preferably with medical devices.
- 3+ years of Medical Device Regulatory Affairs experience required.
- RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
- General understanding of product development process and design control.
- Thorough understanding of FDA and international medical device regulations.
- Previous experience with Class II/III medical devices preferred.
- Previous experience drafting regulatory submissions required.
- Experience interacting with regulatory agencies preferred.
Stryker offers a comprehensive benefits package, including medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program, and tobacco cessation program. We also offer a 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.
Stryker is an equal opportunity employer. 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.
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