Medical Devices Regulatory Affairs Specialist
3 weeks ago
Regulatory Affairs Specialist (Contract)
Yolk Recruitment Ltd is partnering with a growing medical device manufacturer to find a Regulatory contractor.
You'll support a range of regulatory activities, including:
- Supporting with world-wide regulatory submissions.
- Reviewing and managing standards database and advising/implementing changes to the technical files as required.
- Supporting the creation and implementation of compliant Regulatory procedures.
You'll need:
- 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 2017/745 CE compliance and marking.
- EC 60601 family compliance ETL/UL marking.
- ISO 14971 Risk analysis.
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