Regulatory Affairs Engineer - Essex, United Kingdom - SRG

SRG
SRG
Verified Company
Essex, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
Key Tasks

  • Assists the QARA Manager for ensuring compliance with the requirements set by the EU MDD, EU MDR, US FDA CFR, Australia TGA and other regulatory bodies.
  • Compile and submit product registrations with MHRA and Authorised Representative within regulatory timeframes.
  • Provide regulatory input and assess regulatory impact of changes for CRs and NPIs to support new product developments and major extensions to existing product lines.
  • Responsible for preparation and regulatory review of key compliance records (e.g., Labelling and Instructions for use, incl. UDI requirements) for all markets in which the company's products are sold.
  • Review relevant technical information regarding product material and manufacturing processes in line with ASTM/ISO and other relevant standards for product investigations.
  • Complete administrative activities regarding maintaining regulatory files.
  • Participate in implementation of a new eQMS software

Skills & Experience:

  • Knowledge of Regulatory Affairs within a regulated environment (ideally Medical Device or Pharmaceutical)
  • Good team player
  • Good communication skills


Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

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