Regulatory Affairs & Quality Assurance Manager – Medical Devices
Our client is a growing medical device company based in Hampshire, they are looking for a Regulatory Affairs & Quality Assurance Manager to join their team of experts.
This is an excellent opportunity or a RA/QA Specialist / Manager to work in a stand-alone within a small team.
Our client is a privately owned, established and dynamic business offering a hands-on role with a good level of autonomy.
If you have gained good experience within a RA/QA focused position and are ready for a new challenge, please apply today or contact Indo Professionals for more information.
Josh@indoprofessionals.co.uk / 01256 597 800
Regulatory Affairs & Quality Assurance Specialist / Manager (non-line)
Hampshire – ideal for a RA/QA Specialist residing in or near the areas of M3, M27, Southampton, Bournemouth, Portsmouth, Salisbury, Eastleigh, Winchester, Basingstoke, Fareham or for someone looking to relocate.
Within the role, the successful RA/QA Manager will be support CE Marking / UK product registrations, managing and coordinating technical files and the companies QMS. Further responsibilities include;
- Issuing MDA’s and FSN’s
- Liaison and coordination with MHRA
- Non-Conformance reporting
- CAPA management
- Managing complaints / product recalls
- MDD/MDR compliance
- Managing internal audits
The ideal applicant for this dual RA/QA vacancy will have up to date knowledge of MDD/MDR as well as strong experience within quality management. Further experience required includes;
- Strong experience of CE marking
- Manufacturing background – ideally
- Expertise within ISO 13485
- Internal Audit qualification or experience
- Strong communication, presentation and influencing skills
- Able to work in an autonomous and hands-on role
Indo Professionals is a staffing specialist to the medical device industry. We focus on finding positions within regulatory, quality and clinical research. We work with our job seekers on a project basis, providing one to one consultation and up to the minute market information. Please contact the team today.