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Regulatory Affairs Specialist – US Market

Regulatory Affairs Specialist – US Market

We are looking for an experience US regulatory affairs specialist to join our growing team in Cambridge to take a senior role in pre-market submissions for new and modified products destined for the US market.

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, humble, 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.

 

Responsibilities

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

  • Providing senior regulatory affairs expertise and guidance into multi-disciplinary team responsible for medical device regulatory submissions in the US
  • Ensuring the implementation of best practice regulatory vision, strategy, policies, processes and procedures to aid and improve business performance
  • Clear communication with regulatory bodies (US FDA), and working with Technology & Medical Affairs functions to bring clarity and address key regulatory requirements
  • Working closely with expert regulatory consultants, and distilling complex regulatory requirements into crystal clear, actionable tasks for the CMR teams
  • Working closely with project managers to ensure that regulatory submissions are delivered to the require quality, on time.

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.

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, preferable in surgical (or otherwise invasive) devices, surgical robotics experience would be ideal
  • 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.
  • Track record of working with US FDA through 510(k), de novo, PMA pathways. IDE experience for devices would be an advantage
  • Experience working with complex electromechanical devices would be advantageous

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. 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.

 

Interested? We’d love to hear from you!

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