Our client (located in Berkshire, West of London) is considered by many as the market leader when it comes to the manufacturing and sales of diagnostic & medical instruments.
Established for over 100 years and with a recent considerable investment into the business, this is an exciting time to join this growing global brand.
Due to continued growth and new projects, we are looking for a Senior Regulatory Affairs Associate with a Medical Devices background to join the QA/RA team. Reporting directly to the Head of QA & RA some of your duties will include: -
* Preparation of Regulatory dossiers for registration submissions to Health Authorities (globally)
* Providing regulatory support across the business and to external customers such as Distributors and Third-Party Manufacturers
* Lead and execute transition of MDD Technical Files to MDR Technical Files
* Creation and maintenance of Essential Requirement Checklists, Technical Files, and Declaration of Conformity for CE Marking
* Experience in assessing and providing input to the Risk Management processes as per the Risk Management for Medical Devices - ISO 14971
* Experience in reviewing and creating Clinical Evaluations for Medical Devices
* Participation in cross-functional product development teams as the regulatory representative; development of regulatory strategies
* Assess changes in regulations and determine regulatory impact
* Reviewing and approving processes, product changes, labelling changes to identify regulatory impact
* Experience in reviewing Promotional and Non-Promotional Marketing Materials
* Overseeing complaint analysis, reporting complaint trends
* Responsible for Post-Market Surveillance (PMS)
* Maintaining current knowledge of relevant regulations and providing input into management review meetings
* Planning and executing internal audits
It is likely the successful candidate will have the following:
* Minimum 2 years Regulatory Affairs experience gained within medical devices.
* Strong understanding of ISO 14971 & ISO 13845
* Previous involvement of set up and/or development of QMS systems
* Working knowledge and practical experience of regulatory & quality guidelines as applied to medical devices.
* Strong communication and relationship building skills
* Be methodical, analytical and highly organised.
* Although not a managerial position, strong leadership and mentoring skills would be desired.
How to apply
If the above sounds like your ideal role and you have the skills and attributes as listed above, please forward your CV in a word document format ASAP.
Key words: Regulatory, RA, Reg affairs, Regulatory Affairs, Medical Devices
Product Quality Assurance
Coaching And Mentoring