Job DescriptionRegulatory Affairs Manager
- Medical Device Company
- £60,000 + Package
- Great location with excellent transport links to London
- Lots of opportunities for growth and professional development
As a key member of the Regulatory Affairs team, you will be responsible for supporting the business as they expand into new Markets – ensuring the business remains compliant with relevant legislation and providing foresight and advanced warning on upcoming legislative changes and the impact they’re likely to have.
Our client are a UK-based Medical Device business who manufacture a range of innovative and exciting products and are market-leaders in their field. As part of their 2020 growth plan, they are expanding into new territories and require a Regulatory Affairs Manager to provide crucial support with these plans.
The successful Regulatory Affairs Manager will be a key member of the Quality and Regulatory Team. As part of the team, you will be responsible for:
- Providing first-class regulatory support for the business as they develop into new territories, including regulatory alignment and managing continued compliance
- Reviewing and advising on document and product changes for regulatory submissions - advising on how this might be impacted by upcoming legislation and how best to mitigate against these risks
- Liaison with 3rd parties, including regulatory agencies and Notified Bodies amongst others.
- Developing process improvement activities; providing critical analysis on what the company is doing well, but focussing on how to do good better.
The successful Regulatory Affairs Manager is likely to currently be working in a similar role within a medical device business. Within that, there are also some key competencies that you’re able to demonstrate:
- A degree in either a scientific or clinical subject is preferable, however we are happy to consider candidates who have experience in-lieu of a degree
- Excellent knowledge of Quality Systems and Manufacturing concepts – including ISO13485 and CFR820
- Familiarity with upcoming Medical Device Regulation and experience of implementing this within a business is also highly preferable.
If you would like to be considered for the opportunity, or to discuss the role in more detail please don’t hesitate to contact Tom at NES Global Talent.