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Job Reference: HH/HQ1207

Regulatory Affairs Specialist

  • Sheffield, South Yorkshire, England
  • Permanent / Full Time
  • Life Sciences Team
  • £40000 - £45000

Job Title: Regulatory Affairs Manager

Salary: £40-45k

Location: Sheffield

Job Type: Permanent and full time

Reporting to the Head of Quality Assurance and Regulatory Affairs, the Regulatory Affairs Specialist is responsible for ensuring that the products comply with all the necessary national and international standards, guidelines and regulatory requirements in the markets where our products are sold. This involves the generation and development of new, and maintenance of existing, product design dossiers, and the company’s quality management system, and regulatory aspects arising therefrom.

Role Specification

  • Develop, manage and maintain the company’s device family technical files and product specific design dossiers ensuring compliance with the relevant regulations.
  • Develop and maintain an excellent understanding of the company’s procedures and products.
  • Keep up to date with changes in regulatory legislation and guidelines together with customer practices in all countries where we market product.
  • Providing sound advice to management throughout the development of new product and product enhancement submissions, to ensure that the principles of the submission accurately reflect the regulatory requirements to aid timely product introductions and certificate renewal processes.
  • Liaise with the company’s notified body/competent authority, and oversee international submission processes
  • Provide regulatory support and insight to support the company’s commercial endeavours.
  • Collaborate with the RA engineers from our distributors and partners, providing assistance for the maintenance of international product registrations.
  • Act as the quality complaint coordinator, ensuring complaints and adverse incidents are addressed in a thorough and timely manner in accordance with the company QMS.
  • Develop and maintain the in-house regulatory/quality databases (e.g. complaints and National Joint Registry database).
  • Assist in the interpretation of standards and testing of the devices.
  • Provide internal auditor support.
  • Assist the Head of QA/RA in the implementation and maintenance of the company’s Quality Management System, and deputise in their absence/as required.

Person Specification

  • Degree educated, or equivalent, in a life science or engineering discipline
  • At least five years’ experience in a medical device regulatory environment.
  • An in-depth knowledge, and appreciation, of the regulatory requirements for placing class III medical devices on the European market. Experience of North America, South America, Asia-Pacific markets would be desirable.
  • Working in a small compliance team environment, must be capable of working on their own initiative, as well as participating in, or leading, cross functional teams.
  • Must be a methodical thinker, capable of making rational judgements from available information and meeting targets in agreed time scales.
  • Good communicator with excellent attention to detail.
  • Computer literate.

If you’re interested in this position, please click apply now. For more details please get in touch with Harvey in the Life Sciences team.

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