Regulatory Affairs Specialist - Nottingham, United Kingdom - Specsavers

Specsavers
Specsavers
Verified Company
Nottingham, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

Competitive salary with an excellent bonus plan: We offer two bonuses (personal performance paid quarterly and company performance paid annually) with private healthcare and dental cover and a generous pension scheme.

For over three decades our purpose hasn't changed: we are here to make a positive difference to the lives of all.

Through the exceptional products, services and value we offer, we are proud of how far we've come as a business, now we want to see you grow with us.


Your purpose:


As the Regulatory Affairs Specialist, you will be key in supporting the RA Manager and our quality management system in reviewing and keeping up to date with all legislative and procedural changes, assessing the impact to Specsavers and escalating with all relevant stakeholders, to ensure the company adheres to regulatory requirements.


Your role

  • Assist in the review of current global legislation (EU, UK, Canada, AUs, NZ) for changes to legislation affecting technical file information and submissions and/or status requirements.
  • Support the RA Manager to monitor and identify any changes to relevant medical device legislations and standards that will impact Specsavers
  • Ensure that PMS, PSUR and PMCF reports are conducted and maintained

What you'll bring

  • Minimum of 1 years' experience working within the medical devices industry. Working with Class IIa and above medical devices
  • In depth knowledge of EU MDR 2017/745 and UK MDR 200
  • Technical File compilation and maintenance
  • Clinical Evaluation Reports (CER's) creation and maintenance
Happy to talk flexible working
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