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Regulatory Affairs Associate

Buckinghamshire   •  24-28K  •  Permanent, Full time


The role is focused on creating and maintaining technical file, design dossiers and PMA submission.

The candidate will have a good science degree with experience of working in the medical device industry, preferably in a regulatory or QA role

Duties:

  • Compile and submit regulatory submissions for approval to regulatory authorities worldwide.
  • Maintain current registrations, licenses, Regulatory Certification, and submissions to ensure compliance with the latest medical devices regulations.
  • Compile and maintain Technical Files, Design Dossiers, PMA and 510(k) files.
  • Supporting and advising other functions within the business for information requests, drug tariff applications, review of agreement, artwork and literature review.
  • Provide regulatory input to new product developments and major extensions to existing product lines.
  • Support customer market registration activity, within the terms of existing contractual obligations.
  • Responsible for regulatory review and approval of key compliance records (e.g. Labelling and Instructions for use) for all sites.
  • Support Technical File and Design Dossier audits/reviews by Notified Bodies, competent authorities or customers.
  • Participate in company quality system audits.
  • The successful candidates will have at least 2:1 degree in Physics, Chemical Engineering or related subjects with experience in healthcare device development industries.
  • The candidate will have excellent communication skills both written and verbally with employees, customers and suppliers.

Skills: Good knowledge of MDR, ISO 13485, experience with 510(k) applications, Science based degree, Regulatory Affairs/QA

All applicants must be eligible to live and work in the UK.


You must have the right to work in the UK. Learn more

  • Agency: ST Recruitment
  • Contact: Sam
  • Phone: 01737241823
  • Reference: BTO16
  • Posted: 23rd September 2022
  • Expires: 21st October 2022

ST Recruitment

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