Regulatory Affairs Manager

Personnel Futures Limited
08 Mar 2018
17 Mar 2018
Contract Type
Full Time

Our client are a leading medical technologies company now looking to recruit for a Regulatory Affairs ManagerYour Responsibilities:

  • Liaise with QA/RA management throughout the global organisation to ensure consistent global approach to regulation compliance.
  • Identify potential changes to regulations, review impact and make timely notification to the business to ensure compliance is maintained.
  • Ensure current regulations and standards are available.
  • Generate and maintain the DMR/DofC.
  • Attend and support Design review activity and generate environmental checklist, labelling, IFU and ER checklist.
  • Manage ECR/ECO process including notification to S-BCs of changes which are notifiable under regulations.
  • Initial review of complaints to determine and record reportability.
  • Ensure reportable events are reported within timescales as required by all market regulations. Notify senior management as appropriate.
  • Determine whether FSCA is required and generate a Recall File as necessary. Manage all activities and ensure Recall file is regularly updated.
  • Support and supply information as required relating to Product Registration in any market including site /establishment registrations including FDA 510(k), CE Marking etc.
  • Support Change management process (ECR/ECO) and report changes to S-BCs as appropriate.
  • Participate in Continuous Improvement activities
  • Undertake any assignment or duty as required by business needs.
  • Adequacy and regular review of Technical File /Risk Management in accordance with current regulations.
  • Maintenance of SOPs
  • University degree in a scientific / engineering subject.
  • At least five to ten years experience in a regulatory or quality role for a medical device manufacturer.
  • Ability to perform ISO 9001 / 13485 audits and good understanding of EU MDD/MDR, FDA QSR and JPAL requirements and other key international regulations covering medical and industrial devices.

Your Qualifications:

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