Regulatory Affairs Manager / England

Regulatory Affairs Manager

• Medical Device Company
• £60,000 + Package
• Great location with excellent transport links to London
• Lots of opportunities for growth and professional development

We are currently helping a Medical Device Manufacturer to achieve their ambitious growth plans for 2020 with the recruitment of a Regulatory Affairs Manager to their expanding Quality and Regulatory team.
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.

The Business:
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 Role:
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 Candidate:
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.