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Regulatory Manager

Adecco
Job LocationStoke-on-Trent
EducationNot Mentioned
Salary50,000 - 60,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Adecco is looking to hire a Regulatory Manager to support a Medical Device business on a permanent basis.Working with a small team of Regulatory Specialists you will oversee the compliance of new and existing products to ensure they meet relevant regulatory standards and support commercial activities in target markets.With several different projects running concurrently, some of the main areas of focus will be:

  • Creating and maintaining Technical documentation for new and existing products to ensure MDR compliance
  • Managing global registrations
  • Leading a small team of Regulatory Specialists, monitoring performance and identifying gaps within the company resource
  • Acting as the RA Lead for all Notified Body audits (MDSAP and ISO 13485)
This is an extensive position and so the company will need to see the following experience:
  • Conversant with EU, APAC or US, with experience in submitting medical device applications to the notified bodies
  • Comprehensive experience working through a technical file for new and existing products
  • 5 years of regulatory experience in Medical Device design & manufacture
This role gives you the autonomy to take ownership of a growing regulatory department and make it your own.If this position is of interest, please get in touch ASAP.Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.

Keyskills :
RegulatoryMDRregulatory affairssubmissiontechnical file

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