Title: Regulatory Affairs Manager
Summary:
A leading global medical device company is seeking a Manager of Regulatory Affairs to join their innovative team. This key role involves managing regulatory submissions, including 510(k) filings, and working with both the US FDA and EU EMA to ensure compliance with regulatory standards. The Manager will collaborate with cross-functional teams to develop and execute regulatory strategies, prepare high-quality documentation, and support product development efforts. This position offers an exciting opportunity to contribute to the advancement of cutting-edge medical technologies that improve patient outcomes worldwide.
The Manager will be responsible for…
- Offering guidance, leadership, and coaching to Regulatory Affairs (RA) Associates.
- Providing expert technical advice on regulatory requirements for new products and modifications to existing ones.
- Managing, preparing, and reviewing regulatory submissions, including 510(k) filings and compliance with EU MDR standards.
- Collaborating with departments and cross-functional teams to communicate regulatory strategies effectively.
- Evaluating advertising and promotional materials to ensure alignment with local and international regulations.
The Manager should have the following qualifications:
- Holds a bachelor's degree in engineering or physical/biological sciences.
- Possesses 8 years of experience in Regulatory Affairs, including 1+ year of direct or indirect management experience.
- Extensive experience with 510(k) filings and EU MDR submissions.
- Comprehensive knowledge of U.S. and international regulatory requirements for medical devices.
- Proven ability to provide leadership and mentorship to less experienced team members.
- Skilled in identifying, understanding, and resolving regulatory challenges.
