Medical Device Regulatory Manager

Job Type
Permanent
Job Location
England
Job Area
Pharma
Salary Description
Competitive
bath@staroutico.com

Location: Reading, England

Our client part of a group of lifescience companies, that is rapidly expanding. Operating from a business model of virtual companies, they secure registrations and deliver to market specialist and niche medicines and medical devices.

This role would be working on the Ophthalmic arm of the business and responsible for all Medical Device regulatory and compliance activities across UK, EU and US markets.

Medical Device Regulatory Manager:

  • To provide regulatory advice and expertise in relation to identifying and implementing changes in regulatory procedure
  • Compile and update technical files for medical device submissions and registrations
  • To manage the QMS system and maintain compliance and SOPs
  • To assist with the groups transition strategy for MDR and FDA regulatory compliance
  • To support the regulatory requirements of new product registration
  • Supporting internal and external audits
  • Review labelling, support promotional and advertising material

The ideal candidate will have/be:

  • At least 5 years experience within Medical Devices regulatory affairs
  • Experience working with EU and US markets
  • Substantial experience with Technical File creation, classification, registration and Notified Body submissions
  • Ophthalmic medical devices exposure preferable

Apply now via this website or contact Rowena in the Bath office.

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