Regulatory Affairs Specialist (Distributor)

The role is to ensure that the business remains compliant with local and international regulations (UKCA & MDR)

Client Details

Our client is an international leader in medical and safety technology, developing pioneering devices, software, services and solutions that people around the world trust.

Description

• Management of the online MHRA Portal to register medical devices for the UK & IE.
• MHRA Portal data maintenance
• MHRA Portal - Management of 'Letters of Designation' for varying manufacturing sites
• Ensure technical documentation availability & accuracy for the registration of medical devices
• Management of the transition of all products from CE to UKCA marking from a distributor perspective

Profile

A successful Regulatory Affairs Specialist should have:

• Experience of working in a medical device reguatory role.
• Trained & competent in ISO 13485:2016. (essential)
• Demonstrate a clear understanding of MDR 2002 Regulations
• Life Science or Business degree (essential).
• Lean Six Sigma knowledge (desirable).

Job Offer

• An attractive salary
• The flexibility to work from home for 2 days a week
• Opportunity to grow and develop in a supportive working environment

We welcome all interested applicants who meet the above criteria to apply for this exciting opportunity as a Regulatory Affairs Specialist in Blyth.