A new instruction within Regulatory Compliance!

The position is with a global manufacturing organisation (non-food) and is being offered initially on a fixed term contract basis for 4 months, whilst the current job holder is seconded elsewhere within the business. The role could develop beyond this point, but at this stage we are unable to guarantee.

Working within the Quality Team, the Regulatory Compliance Specialist is responsible for ensuring current and ongoing compliance of the Quality Management System for the Business for adherence to requirements regarding Medical Device regulatory laws, industry Standards, guidance documents and company procedures that apply to the Business.

The Regulatory Compliance Specialist will have a strong attention to detail and a working understanding of the medical device requirements. This position works directly with site manufacturing, supply chain and distribution in assuring compliance in both product and process. This role will support the Quality Systems Manager in determining the level of compliance risk throughout the business, as well as being the responsible person regarding Standards Management for the business.

Job Summary:
To provide ongoing and up-to-date quality and regulatory compliance information, advice and guidance for the business, ensuring a consistent, effective and compliant approach across the business.

Experience:
Essential: A minimum of 3 years experience in a Quality or Regulatory based role in Medical Devices, Pharmaceuticals or Cosmetics.
Essential: A minimum of 3 years experience of working in Standards Management.
Essential: Previous experience working in a cGMP or ISO 13485 regulated environment.
Desirable: Previous experience in using MRP or ERP systems for stock management.

Education:
Essential: Educated to degree level in a scientific subject (e.g. Chemistry) or equivalent
Essential: Formal auditor training such as Internal or Lead Auditor in ISO 13485 or 9001
Desirable: Formal Regulatory training on MDD/MDR

Hours of Work:
Monday to Friday, 8.30am – 5.00pm
Favourable salary is available largely depending on experience.

If you have the level of experience we are seeking and would like to be considered, please email an up to date CV as soon as possible.





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