Device Regulatory Lead

Are you passionate about ensuring the safety and compliance of medical devices in the healthcare industry? Do you have experience in regulatory affairs and a strong understanding of global regulations? Sanofi is seeking a highly skilled Device Regulatory Lead to join our team and play a crucial role in bringing life-saving devices to market. In this role, you will be responsible for leading regulatory strategies and submissions for our device products, ensuring they meet all regulatory requirements. If you are a detail-oriented, driven individual with a strong background in medical device regulatory affairs, we encourage you to apply for this exciting opportunity.

1. Develop and implement regulatory strategies for medical devices in accordance with global regulations and standards.
2. Conduct thorough reviews of product documentation and ensure compliance with regulatory requirements.
3. Collaborate with cross-functional teams to gather necessary information and data for regulatory submissions.
4. Prepare and submit regulatory submissions, including 510(k) and premarket approval (PMA) applications, to regulatory authorities.
5. Keep up-to-date with changes in regulations and guidelines related to medical devices and communicate any potential impact to the company.
6. Coordinate and lead meetings with regulatory authorities for product reviews and approvals.
7. Act as the primary point of contact for all regulatory inquiries related to medical devices.
8. Maintain and update internal regulatory databases and documentation.
9. Provide guidance and support to project teams on regulatory requirements and timelines.
10. Participate in internal and external audits to ensure compliance with regulatory standards.
11. Collaborate with Quality Assurance and Quality Control teams to ensure compliance with regulations and standards.
12. Stay informed on industry trends and developments related to medical device regulatory affairs.
13. Train and mentor junior regulatory team members on regulatory requirements and submission processes.
14. Communicate with stakeholders, including senior management, on the status of regulatory submissions and any potential issues or delays.
15. Continuously evaluate and improve regulatory processes and procedures to ensure efficiency and compliance.

According to JobzMall, the average salary range for a Device Regulatory Lead in Cambridge, MA, USA is $130,000-$150,000 per year. However, this can vary depending on the specific company, experience level, and additional skills or qualifications of the individual.

Sanofi SA is a French multinational pharmaceutical company headquartered in Paris, France, the world's fifth-largest by prescription sales. Building a More Equitable Future through Inclusive Clinical Trials · Rethinking the science of COPD · Grassroots Manufacturing Solutions for a Healthier Planet.