Description
My client is a large Medical Device Manufacturer in Oxfordshire and due to a department restructure there is now a need for a Senior Regulatory Affairs Associates.Senior RA Associate - 45k
The technical requirements of the candidates are quite similar, the senior role will require more ownership, there will be management expected in the absence of the QA / RA Management team.
General Responsibilities include;
- Maintenance and implementation of policies and procedures.
- Tracking regulatory changes (standards / directives).
- Contact as appropriate with regulatory authorities.
- Review change documentation for regulatory impacts.
- Review and approve labelling, marketing literature and claims substantiation compliance.
- Preparation and maintenance of Technical Files & associated documentation, (e.g. 510(k)s and notes to file.)
- Coordinate the technical file maintenance plans
- Coordinate the Post Market Surveillance Process
- To participate at a department level the operation of the Quality Management System as defined in Standard Operating Procedures and the associated Departmental Procedures, Work Instructions & Regulatory documents.
Essential Requirements;
- Minimum 3 years experience in Medical Device Regulatory Affairs / Quality Assurance
- Essential knowledge of USA FDA QMS, ISO 9001, 13485, Medical Devices Directive, application to Post Market Vigilance (Product Complaints and Recalls) and associated Med Dev guidelines.
- Experience of company representation at country level meetings
- Experience in vigilance reporting & communications with regulatory bodies and authorities
- Internal auditor trained
- Manufacturing experience preferred but not essential
My client is offering a great package on top of the 45k salary and is looking to interview ASAP so if you are interested in hearing more then please send me your CV and I will be in touch shortly.
To find out more about Real please visit www.realstaffing.com