Regulatory Affairs Officer

Contract:
Permanent
Category:
Full Time
Job Sector:
Security / Defence
Region:
South Wales
Location:
Powys
Salary description:
Competitive
Posted:
18/10/2019
Start Date:
ASAP
Recruiter:
SRG
Job Ref:
777549768

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

Company Description

Closing Date:
15/11/2019

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