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Senior RA Specialist / Manager

Oxfordshire   •  Negotiable  •  Permanent, Full time

SRG are proud to be partnering with this IVD manufacturer with over 18 years' experience. The company has manufactured more than 20 million products and has products approved for sale in over 50 countries, including the United States, Europe, as well as Japan and China.

In this role, you will be assisting the Director of Regulatory Affairs and the Head of Regulatory Affairs with the Company's regulatory process and providing Global regulatory support to Sales and Commercial teams for ongoing requests.

Some of the main responsibilities include:

  • To work with the Quality Compliance Manager to ensure that verification and validation activities as well as risk management are carried out to support Global regulatory requirements.
  • To provide support to the company's facilities to ensure that any regulatory needs are covered. This may include international travel to our subsidiaries.
  • Assist with the conduct of Internal and External audits to agreed standards, with regard to the regulatory requirements.
  • To take a central role in the preparation for and implementation of the requirements of global IVD Regulations.
  • To take a central role with documentation and regular communication with regulatory authorities to ensure that we are in compliance with their requirements.
  • To take a central role with the provision of regulatory affairs input to research and development programs in order to ensure that these programs deliver products that are capable of early product approval by regulators.
  • Communication with distributors to ensure good relationship management from a regulatory perspective when required.
  • To assist with the maintenance of OI certification to international quality standards to ensure regulatory compliance (ISO 13485, ISO 17025 and GMP)
  • Deputising for either the Regulatory Director or Head of Regulatory Affairs, wherever necessary

As the ideal candidate, you will be educated to degree level, or equivalent, and have circa 5 years' experience working within IVD/MD regulatory affairs. You will have good knowledge of ISO13485. cGMP, international submissions, and experience with internal and external audits.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

You must have the right to work in the UK. Learn more

  • Agency: SRG
  • Reference: BBBH127027
  • Posted: 17th March 2023
  • Expires: 14th April 2023


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