Regulatory Affairs Specialist - Med Tech (EU MDR & FDA) in Cambridge

Regulatory Affairs Specialist - Med Tech (EU MDR & FDA) in Cambridge

Cambridge Full-Time 40000 - 50000 Β£ / year (est.) No working from home possible
Cmr Surgical

At a Glance

  • Tasks: Ensure medical devices meet global regulatory standards and support submissions.
  • Company: CMR Surgical, a dynamic company in the Med Tech industry.
  • Benefits: On-site role with a purpose-driven team and career growth opportunities.
  • Other info: Collaborate with R&D, Quality, and Manufacturing for innovative solutions.
  • Why this job: Make a real impact in healthcare by ensuring compliance and safety.
  • Qualifications: Experience in regulatory affairs and knowledge of EU MDR and FDA guidelines.

The predicted salary is between 40000 - 50000 Β£ per year.

CMR Surgical in Cambridge is seeking a Regulatory Affairs professional to ensure medical devices comply with global regulatory requirements.

You will support submissions and liaise with R&D, Quality and Manufacturing to embed regulatory thinking early in development.

Key responsibilities include preparing submissions, assessing changes against EU MDR and FDA guidance, and coordinating responses to questions from Notified Bodies.

On-site role with a dynamic, purpose-driven team.

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Regulatory Affairs Specialist - Med Tech (EU MDR & FDA) in Cambridge employer: Cmr Surgical

CMR Surgical is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the heart of Cambridge. Employees benefit from flexible hybrid working arrangements, competitive compensation, and opportunities for professional growth within a pioneering company dedicated to advancing minimal access surgery. Join us to be part of a mission-driven team where your contributions directly impact healthcare outcomes.

Cmr Surgical

Contact Details:

Cmr Surgical Recruitment Team

We think you need these skills to ace Regulatory Affairs Specialist - Med Tech (EU MDR & FDA) in Cambridge

Regulatory Compliance
EU MDR Knowledge
FDA Regulations Knowledge
Submission Preparation
Liaison Skills
Collaboration with R&D
Quality Assurance Understanding