Senior Regulatory Affairs Specialist

1 week ago

West Yorkshire, United Kingdom X4 Life Sciences Full time

A long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their growing business.

They are looking for an individual that is hard working and self-motivated to assist with all things regulatory. Responsibilities will include:

  • Provide technical support to the business, suppliers and customers on all matters relating to the safety, legality and quality of the products purchased and sold.
  • A clear understanding of the legal requirements for labelling and testing within the required product areas.
  • To ensure all products comply with relevant legislation.
  • Produce and maintain up to date technical files for medical devices to the required standards.
  • Ensure all quality and technical issues relating to technical files are resolved effectively. Escalate when necessary to the Technical Manager/Director
  • Assess device related incidents/complaints for medical device reporting requirements. When required, compile and submit reportable events to relevant regulatory authorities in timely manner.
  • Review of complaint and other product related information in order to create annual Post Marketing Surveillance report.
  • Support the introduction of New products by advising on Regulatory requirements when appropriate.
  • Perform Mock recalls as necessary.
  • Directly manage the Regulatory Specialist, training and coaching the to assist you in delivering the key Regulatory objectives.
  • Deliver key training sessions and provide proactive guidance/input across Sales, Marketing, Procurement and Project Management teams for all Regulatory updates impacting the business, products and processes.

Competencies:

  • 3 years experience in Medical devices (class I and IIa).
  • Experience in Technical files and Post market surveillance.
  • Expert knowledge of MDR, ISO13485, UK MDR.
  • Experience interacting with Notified/Approved Body.

Please share your CV at if you are interested in hearing more about the position. As always if anyone in your network may be a good fit, please share their details as we offer a referral bonus upon the successful placement.

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