Regulatory Affairs Specialist

Job Ref: J22986
Sector: Clinical
Sub-sector: Medical Devices
Date Added: 27 July 2017
  • Birmingham, West Midlands, England, UK
  • £1 per Annum
  • Natasha Rollason

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Key responsibilities:

Offer general advice on regulatory strategy for new products and product changes.

Working on 510k submission on a day to day basis with minimal supervision.

Provide updates on the progress of registration processes and other RA group activities to line management when requested.

Assistance with the regulatory compliance of marketing communications/messages.

Contribute to the development and implementation of regulatory policies, procedures and specifications across the company and ensuring that these are compliant with the Quality System.

Undertake CE marking activities and has a good understanding of the requirements of the IVD directive. Ability to recognize post market surveillance issues that require corrective action and reporting.

Education:

Life sciences qualified.

Experience:

A scientific, medical or engineering background.

Significant regulatory experience.

Knowledge of the IVD industry or the medical devices industry.

Knowledge of GMPs/ISO13485, FDA 21 CFR 820 - 510k process, IVDD - CE marking and ROW regulations/registration processes.

Understanding of pre/post marketing regulatory affairs.

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.