Description
My client is a large manufacturer of implantable medical devices based in the UK that is now looking for a Quality & Regulatory Manager to join their Surrey based team.Key responsibilities;
- Maintain the Marketing Authorisations for the U.K., Ireland, Portugal, Netherlands, Norway and other markets.
- Maintain the U.K. Wholesale Dealer Licence
- Ensure Adverse Events, Product Quality Complaints and Safety Requests (Pharmaceutical and Medical Device Products) are escalated and closed as per corporate procedures
- Ensure that DSE assessments are conducted every two years, with new starters and if a member of staff moves desk.
Essential requirements.
- Degree Level education, science, maths or engineering preferred
- At least 3 - 5 years Regulatory experience in the medical device and/ or pharmaceutical field
- Experience of maintaining an effective Quality Management System (ISO 13485) required
- Demonstrated ability to Interpret and simplify medical device and pharmaceutical legislation, and implement effectively in an operational team
- Demonstrated ability to maintain customer focus whilst delivering on mandatory legislative requirements
- Ability to analyse data and produce summary of results
- Solutions orientated with experience of working in a commercial sales environment
My client is looking to interview ASAP so if you believe you have the correct experience then please send me your CV and I will be in touch shortly.