Regulatory Affairs Specialist
3 weeks ago
Yolk Recruitment Ltd is partnering with a growing medical device manufacturer to find a Regulatory Affairs Specialist for a new opportunity.
The successful candidate will support a range of regulatory activities, including:
- Creation and updating of technical files, reports, and procedures.
- Compiling vigilance PMS and PSUR reports.
- Supporting with worldwide regulatory submissions.
- Assisting with Competent Authority registrations, including the MHRA and ECREP.
- Liaising with all departments to obtain required documentation for technical file and registration updates.
- Creating Declarations of Conformity.
- Reviewing and managing standards database and advising / implementing changes to the technical files as required.
- Supporting the management of Patents and Trademarks.
- Supporting the creation and implementation of compliant Regulatory procedures.
The ideal candidate will have:
- Previous experience in Medical Devices Regulatory Affairs and knowledge of UK MDR 2022 UKCA compliance and marking.
- EU MDD 93/42/EEC CE compliance and marking.
- UKCA compliance and marking.
- EU MDR 2017/747 CE compliance and marking.
- EC 60601 family compliance ETL/UL marking.
- ISO 13485 QMS.
- ISO 14971 Risk analysis.
- Patents and Trademarks.
Yolk Recruitment Ltd is a leading recruitment agency specializing in the medical device industry. We are committed to finding the best talent for our clients and providing exceptional service to our candidates.
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