Description
This role will be principally responsible for compliance with all prevailing medical devices standards and leading the creation and maintenance of all technical files, design dossiers and device master records including certification and all other important documentation for devices. Key responsibilities include;- Support the Group RA/QMS Manager in ensuring that all MR responsibilities are fully discharged including management reviews, CAPA management etc.
- Advise on the appropriate RA pathway and risk management programmes for regulatory issues.
- Advise/act on implications of new or amended standards relevant to the medical devices manufactured by the business.
- Maintain Notified Body Approval for Class II & III medical devices.
- Working with development and commercial teams, agree priorities and clearly convey project timelines, risks and opportunities.
- Ensures the technical documents are in a state of audit/inspection-readiness.
- Support the registrations team where required.
- Plan and co-ordinate internal and external audits as required.
- Co-ordinate continual improvements of the QMS, ensuring that evidence of corrective and preventive actions taken are recorded and reviewed.
Requirements/Qualifications;
- A minimum of scientific degree or equivalent plus appropriate experience in regulatory affairs; the length of which is dependent on the level of qualifications achieved
- 2-3 years experience would be considered however ideally looking for 4+
- Sound Medical Device experience, including demonstrated responsibility for creation and maintenance of technical files and/or Design Master Records
- Knowledge of and experience of design dossiers will be advantageous
- Sound knowledge of relevant Quality Standards
My client is looking to pay between £30-40,000, depending on experience. So, if you are looking to further your career and move in to management, or if you are in management and looking for a new challenge please send me your CV and I will get in touch shortly.
To find out more about Real please visit www.realstaffing.com