Regulatory Affairs Specialist

1 month ago


Edinburgh, Edinburgh, United Kingdom ESS Recruit Full time

Job Overview

Educational Services Scotland's client is a well-established bio-manufacturing organisation, with an internationally recognised product portfolio. They offer contract services to the bioscience industry and manufacture products for major global players in the Life Sciences sectors.

Responsibilities

  • Develop regulatory strategies and manage product license registration with international authorities.
  • Prepare and submit regulatory documentation to FDA, European Notified Bodies, and other relevant agencies.
  • Review analytical data and advise on required information for successful license applications.
  • Maintain product regulatory documents and technical files to ensure ongoing compliance with ISO13485 and FDA regulations.
  • Liaise with regulatory authorities and external bodies to collate and interpret specialised information.
  • Participate in product development projects to provide guidance on regulatory requirements.

Requirements

  • A degree in a relevant field and/or experience in a Regulatory Affairs environment.
  • The ability to prepare coherent regulatory reports and filings.
  • Effective communication skills for handling external interactions with staff from regulatory bodies, customers, distributors, and suppliers.

What We Offer

This is an excellent opportunity to join a thriving Scottish business as part of a larger UK-based blue chip company, launching new products and expanding into medical devices and volume manufactured consumables.

A competitive basic salary of £55,000 plus benefits, including a company pension, healthcare, and bonus scheme.



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