Regulatory Compliance Specialist for Medical Devices
4 days ago
Lifelancer is seeking a highly skilled Regulatory Compliance Specialist to join our team. The ideal candidate will have experience in medical devices regulatory affairs and knowledge of UK MDR 2022, EU MDR 2017/747, and EC 60601 family compliance.
Responsibilities- Creation and updating of technical files, reports, and procedures.
- Compiling vigilance PMS and PSUR reports.
- Supporting 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.
- Support Management of Patents and Trademarks.
- Supporting the creation and implementation of compliant Regulatory procedures.
We are looking for a highly motivated individual with:
- Previous experience in Medical Devices Regulatory Affairs.
- Knowledge of UK MDR 2022, EU MDR 2017/747, and EC 60601 family compliance.
- Strong understanding of ISO 13485 QMS and ISO14971 Risk analysis.
- Familiarity with Patents and Trademarks.
The estimated salary range for this position is £40,000 - £60,000 per annum, depending on experience and qualifications.
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