Regulatory Compliance Specialist for Medical Devices

4 days ago


Bristol, Bristol, United Kingdom Lifelancer Full time
Job Description

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.
Requirements

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.
Salary Information

The estimated salary range for this position is £40,000 - £60,000 per annum, depending on experience and qualifications.



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