Regulatory Affairs Specialist

Job Ref: J23736
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 27 September 2017
  • Birmingham, West Midlands, England, UK
  • Competitive
  • 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.