Regulatory Manager

Join a mission‑driven team leading the next wave of implantable cardiac technology and make a visible, lasting impact on the future of patient care.

R&D Partners is seeking a Regulatory Manager to lead regulatory strategies and manage documentation for a Class III implantable medical device. This role involves working closely with cross-functional teams to ensure compliance and support clinical trials, contributing to the development of innovative technology that has the potential to transform patient care.

Responsibilities:

• Develop and oversee regulatory strategies for EU MDR and global market submissions.
• Prepare and manage regulatory documents during clinical development.
• Provide guidance on regulatory requirements for Class III medical devices.
• Support clinical trials by ensuring all necessary regulatory documentation is in place.
• Collaborate with internal teams to align regulatory processes with quality and design standards.
• Communicate with regulatory authorities and notified bodies as needed.
• Stay updated on changing regulations and propose innovative solutions to streamline product development.

Key Skills and Requirements:

• Experience in regulatory affairs within the medical device industry.
• Knowledge of EU MDR and pathways for Class IIb-III devices.
• Familiarity with managing documentation and regulatory submissions.
• Strong communication and collaboration skills.
• Ability to work in a fast-paced environment and provide proactive solutions.
• (Desirable) Experience with cardiovascular devices or global submissions (e.g., FDA PMA).

For more information, please contact Toby Shelton.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you’ve read and understood our privacy policy, which informs you how we process and safeguard your data – https://www.r-dpartners.com/privacy-policy/