Sr. Regulatory Affairs Specialist Canada

Welcome to Medtronic, a global leader in medical technology, services, and solutions. We are currently seeking a highly skilled and experienced Sr. Regulatory Affairs Specialist to join our team in Canada. In this role, you will play a crucial role in ensuring our medical devices and products meet all regulatory requirements in Canada, allowing us to bring innovative and life-changing therapies to patients in need. Our ideal candidate is passionate about regulatory affairs, has a strong understanding of Canadian regulations, and is committed to upholding the highest standards of quality and compliance. If you are looking for a challenging and rewarding career in the healthcare industry, we want to hear from you!

1. Oversee and manage all aspects of regulatory affairs for Medtronic in Canada.
2. Ensure compliance with all relevant Canadian regulations and standards for medical devices and products.
3. Develop and maintain strong relationships with regulatory authorities in Canada.
4. Stay up-to-date with any changes or updates to Canadian regulations and communicate them to relevant stakeholders within the company.
5. Provide guidance and support to cross-functional teams regarding regulatory requirements and submissions.
6. Prepare and submit regulatory submissions, including pre-market notifications, license applications, and renewals.
7. Coordinate and lead regulatory agency inspections and audits.
8. Conduct risk assessments and ensure all necessary documentation and reports are completed and maintained.
9. Collaborate with internal teams to ensure timely and accurate completion of regulatory requirements for new product development and post-market changes.
10. Serve as the primary point of contact for all regulatory inquiries and requests.
11. Monitor and track regulatory timelines and ensure timely completion of submissions and approvals.
12. Maintain all regulatory documentation and records in accordance with internal and external requirements.
13. Participate in continuous improvement efforts to enhance the regulatory processes and procedures within the organization.
14. Communicate and educate internal stakeholders on changes in regulations and their potential impact.
15. Represent Medtronic in industry organizations and actively participate in discussions and initiatives related to Canadian regulations and standards.
16. Participate in training and development opportunities to stay current with industry trends and regulations.

According to JobzMall, the average salary range for a Sr. Regulatory Affairs Specialist Canada in Brampton, ON, Canada is between $80,000 and $120,000 per year. This may vary based on the specific company, industry, and level of experience.

Medtronic plc is the world's largest medical device company that generates the majority of its sales and profits from the US healthcare system and is headquartered on the island of Ireland.