Senior Regulatory Affairs Specialist

Are you a detail-oriented individual with a passion for navigating complex regulatory landscapes? Are you looking for an opportunity to utilize your expertise in the medical device industry? If so, Stryker is seeking a Senior Regulatory Affairs Specialist to join our team. This role requires a highly organized and knowledgeable professional who will be responsible for ensuring compliance with all applicable regulations and standards for our innovative medical devices. If you possess strong communication skills, a keen eye for detail, and a drive for continuous improvement, we invite you to apply for this exciting opportunity.

1. Develop and maintain a deep understanding of all relevant regulations and standards for the medical device industry.
2. Ensure compliance with all applicable regulations and standards for Stryker's medical devices.
3. Monitor changes in regulations and communicate updates to relevant stakeholders.
4. Collaborate with cross-functional teams to ensure regulatory requirements are met in product development, manufacturing, and distribution processes.
5. Prepare and submit regulatory submissions to obtain approvals for new products, changes to existing products, and international market access.
6. Conduct thorough research and analysis to determine the impact of new or updated regulations on Stryker's products.
7. Advise and guide the organization on regulatory matters, including potential risks and opportunities.
8. Maintain up-to-date regulatory documents and records.
9. Participate in regulatory agency inspections and audits.
10. Proactively identify areas for process improvement and implement solutions to streamline regulatory processes.
11. Provide guidance and training to other team members on regulatory compliance.
12. Stay current with industry trends and developments related to regulatory affairs.
13. Communicate with regulatory agencies and respond to inquiries or requests for information.
14. Collaborate with external consultants and experts as needed.
15. Ensure all regulatory activities are completed within established timelines and budget.

According to JobzMall, the average salary range for a Senior Regulatory Affairs Specialist in Mahwah, NJ 07430, USA is between $90,000-$120,000 per year. However, this can vary based on factors such as the company, experience level, and specific job responsibilities.

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.