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Regulatory Affairs Manager Medical Devices

Page Group
Job LocationEssex
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Exciting opportunity to join a world leading medical device business who are constantly updating, developing and releasing new life changing technology.Client DetailsMy Client is a world leading medical device business who are constantly updating , developing and releasing new life changing technology. Due to continuous growth my client is now looking for a Regulatory Affairs Manager - Medical Devices to join the team.DescriptionRegulatory Affairs Manager - Medical Devices

  • Identify potential changes to regulations, review impact and make timely notification to the business to ensure compliance is maintained.
  • Support and generate updated technical documentation for Medical Device File.
  • Manage Engineering Change Request (ECR/ECO) process where regulatory actions are required.
  • Manage and implement Field Safety Corrective Actions and provide feedback to Competent Authorities where required.
  • Liaise with internal and external resources, Competent Authorities and Notified Bodies to ensure timely delivery.
  • Participate in Continuous Improvement activities
  • Undertake any assignment or duty as required by business needs.
  • Adequate and regular review of Medical Device File/Risk Management in accordance with current regulations.
  • Provide training in RA and FSCA processes of internal stakeholders, Subject Matter Experts and other RAQA resources.
    • ProfileRegulatory Affairs Manager - Medical Devices
  • University degree in a scientific subject
  • Minimum of 3 to 5 years post qualification experience in regulatory affairs, quality or R&D in the medical device and/or pharmaceutical industry in product registration, medical device file and/or technical compliance activities.
  • Good understanding of EU MDD/MDR, ISO 13485 and MDSAP requirements and ability to communicate and provide training on these technical and regulatory documents to a less specialist audience.
  • Knowledge from a registration perspective of active medical devices, risk assessment, clinical experience, post-market surveillance, quality compliance.
    • Job OfferGet in touch to find out more about the excellent package

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