Clinical Regulatory Affairs Specialist

  • AES
  • Dec 05, 2022
Full time Engineering

Job Description

Position: Clinical Regulatory Affairs Specialist Location: Cambridgeshire Salary: £45,000 to £55,000 (Negotiable) + Excellent Benefits / Prospects (including Relocation Assistance) If there is something stopping you from achieving all you re capable of, you ll relish a role with a company that will positively encourage you to be pro-active a real opportunity to release your true potential. The Company: Our Client, an innovative dynamic passionate Company that manufactures minimal invasive next-generation robotic-assisted medical devices that are at the forefront of how surgical procedures are carried out. An award-winning company that plans to significantly disrupt the way surgery is performed for the benefit of millions of patients all around the world. Due to sustained continued expansion they now require proactive Clinical Regulatory Affairs Specialist, to ensure all the post market regulatory clinical activities are performed and up to date. Other responsibilities include but are not limited to: Advising and steering the clinical team in clinical trials, clinical investigation and clinical development plan. Oversight of clinical development (pre-and post-market activities) as well as overall responsibility for clinical operations and documentation in the run-up to the conformity assessment and application submission for market authorisation The Person: Candidates suitable for consideration should be able to provide evidence of the following: Degree qualified in Science or Engineering or equivalent on the job experience. Working knowledge of regulatory compliance in Europe, USA, China and Japan, and a track record of successfully gaining regulatory approvals in various markets. Clinical Regulatory Experience in the medical device industry is essential The successful candidate will enjoy a salary of between £45,000 to £55,000 (DOE & Negotiable) + Excellent Benefits / Prospects (including Relocation Assistance) plus excellent prospects and an employment package that you would expect from a company that values its employees. Do you have the courage to take on this challenge