|Location: Cambridge||Salary: £45000 - £55000 per annum|
|Sector: Medical Devices||Specialism:|
|Type: Permanent||Contact: Matt Henocq|
Regulatory Affairs Specialist
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.
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 my cleints teams
- Working closely with project managers to ensure that regulatory submissions are delivered to the require quality, on time.
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.
Services advertised by Gold Group are those of an Agency and/or an Employment Business.