Regulatory Manager

  • Location
    Holywell, Flintshire
  • Salary
    £ 50000 - £ 60000 / Year
  • Job type
  • Industry
  • External Reference
  • Category
    Engineering, Aerospace, Automotive - Engineering, Aerospace, Automotive

Adecco is looking to hire a Regulatory Manager to support a Medical Device manufacturer on a permanent basis.

This position will see you be the sole person responsible for Regulatory Affairs across the business and so extensive knowledge of regulatory activities is essential, although you will be closely supported by both the quality and new product development teams.

Working with Class i and iia products you will oversee the compliance of new and existing products to ensure they meet relevant regulatory standards and support commercial activities in target markets.

With several different projects running concurrently, some of the main areas of focus will be:

  • Completing MDR compliance, working through remaining technical product families

  • Expanding product submissions with a particular focus on the Middle Eastern market

  • Developing the businesses product expansion throughout the EU

  • Focusing on UKCA marking

  • Co-ordinating the new product development teams (budget review, reporting)

This is an extensive position and so the company will need to see the following experience:

  • Conversant with EU, APAC or US, with experience in submitting medical device applications to the notified bodies

  • Comprehensive experience working through a technical file for new and existing products

  • 5 years of regulatory experience in Medical Device design & manufacture

  • Financial or budgetary management experience

The business has multiple sites across the UK, and so although the role can be flexible with home working and location, there will be an expectation to travel UK-wide throughout the year.

What's in it for you?

Alongside the autonomy to take ownership of a growing regulatory department and make it your own, some headline benefits include a car allowance, a performance and company-based bonus of up to 20%, and private healthcare.

If this position is of interest, please get in touch ASAP.

Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.

To speak to a recruitment expert please contact Amy Holder