Senior Regulatory Affairs Specialist

Welcome to Stryker, a global leader in medical technology and innovation. We are currently seeking a highly experienced and driven Senior Regulatory Affairs Specialist to join our team. This role offers the opportunity to make a significant impact in the healthcare industry by ensuring compliance with regulatory requirements for our life-saving products. As a Senior Regulatory Affairs Specialist at Stryker, you will play a crucial role in obtaining and maintaining regulatory approvals for our products, while also providing strategic guidance to cross-functional teams. If you have a strong background in regulatory affairs and a passion for improving patient outcomes, we encourage you to apply.

1. Develop and maintain a thorough understanding of global regulatory requirements for medical devices and ensure compliance with these regulations.
2. Prepare and submit regulatory submissions for product approvals, including 510(k) and PMA applications to the FDA.
3. Collaborate with cross-functional teams to ensure timely and successful completion of regulatory submissions and approvals.
4. Conduct gap analyses and risk assessments to identify potential regulatory issues and develop mitigation strategies.
5. Review and approve product labeling, promotional materials, and other documentation to ensure compliance with regulatory requirements.
6. Stay current with industry trends and changes in regulations to provide strategic guidance on regulatory matters to internal stakeholders.
7. Assist with regulatory agency inspections and audits, and coordinate responses to any findings.
8. Manage and maintain regulatory files and documentation, ensuring accuracy, completeness, and timely updates.
9. Monitor and communicate changes in regulatory requirements and ensure timely implementation of any necessary changes.
10. Mentor and train junior regulatory affairs team members to ensure compliance with company policies and procedures.
11. Collaborate with external partners, including consultants, regulatory agencies, and notified bodies, to ensure successful product approvals.
12. Participate in company-wide projects and initiatives to improve regulatory processes and procedures.
13. Uphold Stryker's values and code of conduct while representing the company in interactions with regulatory agencies and external partners.
14. Continuously strive for process improvement and contribute to the development and implementation of best practices for regulatory affairs.
15. Provide guidance and support to cross-functional teams on regulatory requirements and potential impacts on product development and commercialization.

According to JobzMall, the average salary range for a Senior Regulatory Affairs Specialist in Ann Arbor, MI, USA is $80,000 to $110,000 per year. However, this can vary depending on the specific company, industry, and level of experience of the individual. Some companies may offer higher salaries or additional benefits for this position.

Stryker Corp. is engaged in providing medical technology products and services. It operates through the following segments: Orthopaedics, MedSurg and Neurotechnology and Spine. The Orthopaedics segment provides reconstructive and trauma implant systems. The Medsurg segment deals with surgical instruments and equipment, endoscopy, patient handling, and reprocessed medical devices. The Neurotechnology and Spine segment pertains to spinal implants and neurovascular products.