Senior Regulatory Affairs Specialist

Are you passionate about making a positive impact in the healthcare industry? Do you have a strong background in regulatory affairs and a desire to lead and mentor a team? We are seeking a dynamic Senior Regulatory Affairs Specialist to join our team at Stryker. In this role, you will be responsible for ensuring compliance with regulatory requirements and guiding the development and approval of new medical devices. As a leader in our organization, you will have the opportunity to make a significant contribution to the success and growth of our company. If you have a strong attention to detail, excellent communication skills, and a proven track record in regulatory affairs, we encourage you to apply for this exciting opportunity.

1. Lead and manage a team of regulatory affairs specialists to ensure compliance with all relevant regulatory requirements.
2. Develop and maintain relationships with regulatory agencies to facilitate the approval process for new medical devices.
3. Keep up-to-date with changes in regulatory policies and communicate any potential impacts to the organization.
4. Collaborate with cross-functional teams to guide the development and approval of new medical devices.
5. Ensure that all product labeling and promotional materials are compliant with applicable regulations.
6. Proactively identify and mitigate potential regulatory risks and issues.
7. Conduct thorough reviews of all regulatory submissions to ensure accuracy and completeness.
8. Maintain all necessary documentation and records to support regulatory submissions.
9. Mentor and train junior regulatory affairs team members to foster their professional growth.
10. Act as a subject matter expert on regulatory affairs, providing guidance and support to other departments within the organization.
11. Participate in regulatory audits and inspections, and implement corrective actions as needed.
12. Collaborate with quality assurance and quality control teams to ensure compliance with all regulatory requirements.
13. Prepare and submit regulatory reports and updates to management and relevant stakeholders.
14. Represent the company in regulatory meetings and conferences.
15. Continuously evaluate and improve internal processes and procedures related to regulatory affairs.

According to JobzMall, the average salary range for a Senior Regulatory Affairs Specialist in Grand Rapids, MI, USA is between $80,000 and $120,000 per year. This may vary depending on the specific company, industry, and level of experience of the individual.

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.