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Regulatory Affairs Associate

North West   •  28-32K  •  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


  • 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 and PMA .
  • 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.
  • To promote health and safety policies in the workplace.

Skills: FDA, , listings and licences, Design Examination Certification. PMA. Regulatory affairs. Medical Devices,

The successful candidate will have an excellent communication skill both written and verbally with employees, customers, and suppliers.

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: BMC06
  • Updated: 28th April 2022
  • Expires: 26th May 2022

ST Recruitment

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