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Contract Regulatory Affairs Officer

Tyne and Wear   •  Contract/Temporary, Full time

Graeme Pallas at CK Group is recruiting for a Regulatory Affairs Officer on behalf of a leading medical diagnostics company at their site near Newcastle upon Tyne on an initial 3 month contract basis.

You will be responsible for ensuring the appropriate licensing, marketing and legal compliance of IVD products. You will advise on and coordinate the approval and registration of products, and will liaise with regulatory authorities including MHRA, FDA and CFDA on behalf of the company.

Your duties will include:
- Creation and development of technical files for the IVD directive.
- Preparation of regulatory submissions for US, Canada, Japan, China and other countries as required.
- Management of Medical Device regulations.
- Providing regulatory input into product development projects, customer complaint handling and other departments as required.
- Post-market surveillance and vigilance
- Submission of regulatory dossiers
- Promotion of regulatory awareness throughout the company

To be considered for the role, you should be an experienced quality or regulatory professional, who has prepared regulatory submissions and technical files for in vitro medical device registrations in key world territories including USA, Canada, Asia Pacific, BRIC and Australia.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46261 in all correspondence.

You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Graeme Pallas
  • Phone: 0191 384 8905
  • Reference: 46261
  • Posted: 9th August 2019
  • Expires: 6th September 2019

CK Group

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