Regulatory Executive - London - California - IVD - 50k+

FDA, IVD, Clinical, Trials, Quality, CAPA, GCP, directives, regulatory, affairs, executive, CLIA, PMA, CFR
Ideal Candidate: The person who have worked with IVD devices Regulatory Affairs and FDA submissions.

Exciting and ambitious job opportunity, for healthcare technology launch in the California!

My client is developing cutting edge IVD technology with a consumer-first approach based in London. Well-funded and with rapidly expanding team, they are looking for skilled and motivated Regulatory Executive. The right person will bring experience taking a product in development through to launch in the USA both via CLIA and eventually via FDA and with post launch surveillance.

The role:
  • Collating scientific and legal documents and ensuring they are regulatory ready for FDA:
- Ensuring compliance, liaising and negotiating;
- Obtaining FDA approved marketing authorisation.
  • Produce and supervise a Quality Policy and a Quality Manual;
- Develop and implement a Corrective and Preventative Action (CAPA);
- Recruiting of laboratory staff and training.
  • Clinical Research:
- Ensuring that studies adhere to FDA regulations, GCP, ISO standards, IVD Directives and policies and procedure of the quality systems;
- Overviewing proposed study protocols to assess factors such as sample collection procedures, data management issues.

The Candidate:
  • Preparation of successful PMA submissions to FDA, including strong knowledge of FDA 21 CFR Part 820.
  • Knowledge of CLIA Certificate of Compliance or Certificate of Accreditation.
  • Working in Clinical Operations in Medical Devices/IVD studies.
  • Having been involved in the regulatory affairs of a diagnostic test during its development.

The Benefits:
  • Rapidly expanding Biotech, working on cutting edge device release.
  • Complex and Exciting Projects.
  • Great Progression Opportunity.
  • Highly Competitive Salary - £40K – 50K plus an excellent Benefits Package.
  • Company is based in London, with frequent travels within UK and USA.

If you think you match the skills listed above and are looking for a new challenge in the Biotech industry, then please apply with your CV or call Egle Lauzikaite on 020 3465 0033 for a completely confidential chat about your situation.


Job type:
Scientific and R&D
Clinical Research
Highly Competitive
Apply Now

Talk to a consultant

Talk to Egle Lauzikaite, the specialist consultant managing this position, located in London City

4th Floor, 107 Cheapside

Telephone: 02034650033

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