Regulatory Affairs Officer

Powys | Defence

Our client a Manufacturing Company have opened a new vacancy within their Regulatory Affairs team, and are looking to recruit a Regulatory Officer on a permanent basis to be located at their offices in Wales.

The Role:

To be responsible for meeting regulatory compliance to appropriate medical devices directives, guidance notes & standards. Meeting and maintaining regulatory compliance to CLP and other legislation and guidance related to chemical manufacturing & supply.

Key Responsibilities/Requirements:

  • Liaise with external interested parties in relation to compliance (e.g. MHRA, Natural Resources Wales, Customs & Excise, international equivalents, customers & suppliers).
  • Maintaining and enhancing technical files for existing and future products.
  • Keeping up to date with relevant directives, legislation and guidance/best practice via appropriate channels e.g. MHRA website.
  • Identify and develop record keeping requirements as required by various interested parties including enforcing authorities.
  • Contribute to the development of a continuous improvement culture internally and, where applicable, with interested parties.
  • Provide information to maintain compliance with relevant management systems (e.g. ISO9001:2008, ISO13485:2003, ISO14001:2004)
  • Manage and complete international registrations for products.
  • Maintaining and enhancing safety data sheets (SDS) and product labelling requirements
  • Keeping up to date with relevant directives, legislation and guidance/best practice via appropriate channels e.g. HSE, natural Resources Wales.
  • Identify and develop record keeping requirements as required by various interested parties including enforcing authorities.
  • Develop proactive relationships with the various enforcing agencies
  • Make recommendations to the management team that will enhance performance and provide best practice to exceed requirements of the enforcing agencies
  • Develop understanding and knowledge of relevant members of the company to enable progression to meet and exceed requirements of enforcing agencies
  • Work with management team and relevant staff to enable compliance and growth of the company.

Skills/Experience Required:

  • Degree in: Law, medicine, pharmacy, engineering or another relevant scientific discipline.
  • Knowledge and hands on experience of creating and managing product technical files the relevant technical information required
  • Knowledge and hands on experience of relevant and updated legislation, directives and guidance including Medical Devices and chemical related legislation including CLP.
  • Knowledge and hands on experience of liaising with external interested parties on technical and legislative matters.
  • Working knowledge and experience of medical and in vitro devices.

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or 589673


Register & Apply Now Login & Apply
Advertiser
SRG
Reference
777549768
Contract Type
Expiry Date
15/11/2019 06:56:00
Shortlist Email me jobs like this  Back to listing

Terms of Use/Notifications

Do you agree to our terms & conditions & privacy statement?

Receive updates & notifications from Ex-MilitaryCareers.com