We are looking for a top rate regulatory affairs specialist to join our growing team in Cambridge to assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified product.
Why join us?
CMR is one of the UK’s most exciting companies to be joining right now. The scale of our ambition to build a world-class medical devices company in Cambridge is matched only by the breath-taking innovation that underpins our next generation of surgical robot. We’re an award-winning company that plans to significantly disrupt the way surgery is performed for the benefit of millions of patients all around the world.
Our values are ambitious, people focused and fair and responsible. If you share these values, our passion for improving lives, and have the skills to make a real difference to the way minimal access surgery is developed and delivered, then it’s a great time to join us.
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.
- Reviewing and approving of technical documentation from a regulatory perspective.
- Providing regulatory input to our commercial and development teams in support of penetrating new markets.
- To help educate the business in the quality and regulatory disciplines needed for the control of complex medical devices.
- Knowledge of device sterilisation and validation an advantage.
We’re a high growth company and as such roles change and evolve. We’d expect you to be willing to turn your hand to anything within the Regulatory Affairs remit that helps the team deliver its objectives.
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 organisation and to communicate effectively at all levels
- A demonstrable hands-on approach to regulatory affairs, not being afraid to get involved with real issues and challenge where necessary.
In terms of education, we would 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.
We offer a competitive salary and a great benefits package (including non-contributory pension scheme, cycle-to-work scheme, life assurance, and our legendary monthly 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.