Regulatory Affairs Specialist

Regulatory Affairs Specialist

We are looking for a top rate regulatory affairs specialist to join our growing team in Cambridge.

Responsibilities

Every day will be different but some of your main responsibilities will be:

  • Assisting with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
  • Preparing document packages for regulatory submissions
  • Keeping abreast of regulatory procedures and changes
  • Reviewing proposed product changes for impact on their regulatory status
  • Communicating with regulatory and governmental agencies
  • Reviewing proposed labelling, promotion and advertising material for its compliance with applicable global regulations
  • Responding to requests from foreign government and/or distributors as needed.

About you

Naturally you’ll have a thorough & sound working knowledge of regulatory compliance in Europe, USA, China and Japan, and a track record of successfully gaining regulatory approvals in various markets. We’d also look for you to have:

  • Experience in the medical device industry
  • A strong attention to detail and the ability to multi-task and balance competing priorities
  • The ability to build relationships between Regulatory Affairs and other areas of the organization and to communicate effectively at all levels
  • A demonstrable hands-on approach to regulatory affairs, not being afraid to get involved with real issues.

In terms of education, we’d like you to have a Degree or higher in a relevant life science, scientific or engineering-based discipline, but a combination of education and experience may be considered. Being computer literate is essential; good written & verbal English also necessary. You’ll also need to be able to travel occasionally when required.

 

The package

We offer a competitive salary and a great benefits package (including pension, cycle-to-work scheme, life assurance, and medical insurance – as well as our now famous monthly company BBQs). On top of that, you’ll be joining a company with a fabulous culture of ambition, creativity and teamwork, and where fun is just as valued as our commitment to make surgery better for millions of people.

Why join us?

CMR Surgical is developing a next-generation robotic system for universal keyhole surgery. The Versius system comprises a surgeon console, modular light-weight robotic arms and a range of wristed 5 mm fully-instruments. In short, we’re creating something truly amazing designed to improve the lives of people around the globe; it’s a vision that excites us and hopefully will excite you.

Versius overcomes obstacles to widespread adoption of robotic minimal access surgery, namely robot size, instrument size, versatility, port placement, cost and ease of use, allowing the system to be highly utilised and ultimately cost-comparable to manual laparoscopic surgery.

The Company was formed in 2014 and has its headquarters in Cambridge, United Kingdom. We’re privately owned and enjoy strong financial backing.

 

Interested?  Then send your application to careers@cmrsurgical.com.  We’d love to hear from you!

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About CMR

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Versius surgical robotic system

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