Medical Device Regulatory Manager

  • Salary: Up to £50,000 per annum
  • REF Number: 00050009
  • Consultant: Jim Gleeson
  • Contact: 01438 842973
  • Date Published: 22.04.2021
  • Sector: Medical Devices, Ophthalmology
  • Location: Reading, Home Counties
  • Discipline: Regulatory Affairs

CK Group are recruiting for a Medical Device Regulatory Manager to join a specialist Ophthalmology company in the latter stages of bringing a new medical device to market. When safe to do so the role will be office based in Reading for two days a week.

Salary: Base salary of up to £50,000 per annum.

Medical Device Regulatory Manager Role: As Medical Device Regulatory Manager you will be joining a high-performing team and playing a key, strategic role in ensuring the successful commercialisation of their medical device portfolio.

Key duties will include:

  • Providing regulatory advice and expertise in relation to identifying and implementing changes required to the company's quality management system (QMS) in order to maintain compliance with the regulations of all appropriate authorities.
  • Creating and reviewing of Standard Operating Procedures (SOPs).
  • Monitoring medical device regulatory changes and coordination/implementation of appropriate procedural changes within the QMS.
  • Assisting in compiling and updating technical files for new medical device product submissions and registrations. Working closely with all third parties in the process.
  • Management and organisation of internal and external audits. Co-ordinating review of the results ensuring all actions are agreed and implemented in the timescales set.

Your Background: As Medical Device Regulatory Manager you will require:

  • A relevant Scientific or Technical degree.
  • A detailed knowledge ofUS, UK and EU pharmaceutical and medical device regulations.
  • Extensive US and EU regulatory affairs experience in the medical devices field, including Technical File creation, classification, registration and Notified Body submissions.
  • Experience of QMS management.

Apply: For more information or to apply for this Medical Device Regulatory Manager position, please contact Jim Gleeson on 01438 842973 or email jgleeson@ckclinical.co.uk, quoting job ref 50009.

It is essential that applicants hold entitlement to work in the UK.

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