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.