Medical Device Senior Regulatory Affairs Specialist

Posted 18 June by Quality Start
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Medical Device Senior Regulatory Affairs Specialist - Hertfordshire & homebased


This is a great opportunity for a Regulatory Affairs (RA) Specialist to develop your career in regulatory affairs for medical devices.

Do you have medical device regulatory affairs experience? Have you compiled regulatory documents for submissions within the European Union (EU)? Have you compiled and prepared responses to regulatory authorities questions? Looking for a long term contract role with an exciting global medical device company? If yes then this is the role for you.

Your role as a Medical Device Senior Regulatory Affairs Specialist will involve supporting the ongoing maintenance of my clients Class IIa, Class IIb, and Class III medical device portfolio in the European Union (EU).

You will interact with a global team involved with the development of these products, and will be responsible for supporting the coordination and the preparation of documents/packages for global regulatory submissions as well as the lifecycle management of these products.

Essential Duties and Responsibilities:

  • Reviewing, editing and proofreading regulatory documentation.
  • Compiling regulatory documents for submissions (including MDD and MDR change notifications, STED updates, and overseeing updates to technical documentation)
  • Compiling and preparing responses to regulatory authorities questions.
  • Maintaining regulatory files in a format consistent with requirements.
  • Maintaining awareness of regulatory requirements.
  • Maintaining and updating existing regulatory authorizations.
  • Performing EU regulatory assessments on medical device change control.
  • Assisting in the preparation and review of labeling, SOP’s, and other departmental documents, as required.
  • Serving as Person Responsible for Regulatory Compliance (PRRC) for the manufacturing site.

This is a 12 months contract role which will most likely get extended for another 12 months. Everything is dependent on the individual and business performance. There is flexibility to work from home or work at the site in Hertfordshire.

The PAYE rate is £45.61.


To apply for role of Medical Device Senior Regulatory Affairs Specialist you will have the following:

  • Educated to degree level (a scientific/engineering degree).
  • Experience in carrying out the above duties.
  • Good medical device regulatory affairs within the EU.

How to Apply:

To apply for this one off opportunity, please send a word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat. Please ensure you have read and agree to our Privacy Policy which can be found on the Quality Start website.

If this sounds like the role for you or a colleague then please don’t hesitate to contact us. If we manage to successfully fill a permanent placement from your recommendation then we will send you a cheque of £300. We also have many incentive schemes for referring contractors/temp staff so please contact us with the referral and we can provide you with more information.

For a list of our current vacancies, please visit the Quality Start website.

If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.

Quality Start are acting as a specialist recruitment consultancy for this role.

Required skills

  • Medical Devices
  • Regulatory Affairs
  • MDR
  • Regulatory Submissions
  • Technical Files

Reference: 43084625

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