TITLE: Regulatory Affairs Project Manager
DEPARTMENT: Regulatory Affairs
REPORTS TO: Regulatory Affairs Director


The role

Biocomposites continues to experience dramatic growth, realising our mission to increase the number of patients we can help, by extending our market coverage in new specialities and new geographies.

We are continuing to grow in international regions, and now have an exciting opportunity for a Regulatory Affairs Project Manager to join our growing teams here in the UK.

The Regulatory Affairs Projects Manager provides leadership and oversight of regulatory projects and staff including new or renewed product registrations and claims in accordance with regulatory requirements.


What do we offer?

Competitive salary and benefits!With us, you will receive a competitive salary package and benefits.

We grow talent. At Biocomposites we create opportunities to thrive and grow.

One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.


Who do we look for?

People who are passionate about what we do.

People who are open minded to evolving the way we work.

People who can work together to transform outcomes and change lives.


Required experience:

  • Bachelor’s Degree in a life science discipline or equivalent.
  • Minimum 8 Years’ experience with Medical Devices (or pharmaceutical) manufacturer with quality or regulatory responsibilities (i.e. above ‘entry level’ positions).
  • Proven regulatory experience of EU & US medical device regulations as a minimum.
  • Hosted notified body/regulatory agency audits.
  • Compilation of Technical Files/Documentation to MDD 93/42/EEC or MDR 2017/745.
  • Experience of ISO 13485 QMS.
  • Working knowledge of applicable medical device regulations and/or standards).


Location & working pattern

Biocomposites Ltd. / Home working

Keele Science Park, Keele, Staffordshire, England, ST5 5NL

09:00-17:00 (or 08:00-16:00) on-site min 3 days per week expected with additional days according to business needs (e.g. audits requiring on-site attendance, submission deadlines)

If you are interested please forward your CV and cover letter stating the position you are applying for to careers@biocomposites.com