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| Job Location | Stoke-on-Trent |
| Education | Not Mentioned |
| Salary | Salary negotiable |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent , full-time |
* Proven experience of EU and US medical devices regulations* Experience of ISO 13485 QMS.* Compilation of Technical Files/Documentation to MDD 93/42/EEC or MDROur client is seeking a Projects Manager - Regulatory Affairs to provide leadership and oversight of regulatory projects and staff including new or renewed product registrations and claims in accordance with regulatory requirements. This role will be reportingto the Compliance Director and offers the opportunity for hybrid working. This forward-thinking and dynamic business are expanding globally, and this is an excellent opportunity to join a business that is going from strength to strength.* To manage and support regulatory projects including; New product registrations, new product claims, and existing product renewals* Ensure relevant information is submitted to organisations and regulatory bodies for product registration. Such information may be redacted to retain confidentiality and protect proprietary knowledge.* Ensure Technical Documentation is available and maintained.* Assess the impact of design changes on regulatory compliance and the implications for maintaining regulatory compliance* Authority to control further processing or delivery of non-conforming products until the nonconformity is resolved.* Authority to release product on concession if regulatory requirements are met.* Provide leadership, management, and oversight of regulatory staff.* Promote awareness to staff on meeting customer, quality, and regulatory requirements.* Maintain a regulatory management role that is independent of the purchasing, manufacturing, and testing functions.* Report the implications of regulatory changes to Management Review.Candidate Requirements: * Relevant degree or qualification in medical devices or pharmaceutical regulatory requirements* Minimum of 8 years experience with Pharma or medical devices manufacturers* Proven experience with EU and US medical devices regulations* Experience with ISO 13485 QMS.* Compilation of Technical Files/Documentation to MDD 93/42/EEC or MDR 2017/745.* Experience of US 510k/PMA regulation and working knowledge of MDSAP, ISO14971, ISO10993 is desirable Hours: (35 hours) Between 8:00 am - 5:00 pm Salary: Negotiable Brampton Recruitment is an independent Commercial and Accounts & Finance recruitment agency working in partnership with employers spanning Stoke on Trent, Staffordshire, Cheshire, and the Greater Manchester region.