Head of Vigilance

2 months ago

UK, UK, United Kingdom Consult Full time

On behalf of our client, a reputable cutting edge Medical Devices manufacturer with products sold in over 5o countries worldwide, we are looking for an experienced Manager to take on a Head Of Vigilance position.


Scope of the Role:

You will oversee and lead the Vigilance Team, focusing on complaint handling, medical device reporting, and collaboration with manufacturers.

This role plays a key part in ensuring compliance with global regulatory standards and driving strategic initiatives within the company’s quality assurance framework.

The position involves working closely with the regulatory and quality teams to continuously enhance complaint management processes and ensure adherence to safety protocols.


Key Responsibilities:

  • Lead, coach, and mentor a team of vigilance professionals, setting clear goals and performance targets.
  • Manage the intake, evaluation, and reporting of medical device complaints, ensuring compliance with international regulations such as FDA 21 CFR Parts 820 and 803 and the EU Medical Device Regulation (2017/745).
  • Collaborate with internal teams and external manufacturers to resolve product complaints and ensure accurate reporting to global regulatory bodies.
  • Oversee the development of Post Market Surveillance Plans and ensure timely submission of PSUR
  • Provide support during internal and external audits, including addressing CAPAs, nonconformances, and developing quality assurance plans.
  • Lead initiatives to improve quality and efficiency within the complaint handling process.


Candidate Profile:

  • Minimum 10 years’ experience in Quality Assurance or Complaint Management in the Medical Device or Aesthetics sectors. 5 Years of experience minimum in a team leading capacity.
  • In-depth knowledge of relevant regulations, including FDA 21 CFR Part 803, 820, and EU MDR
  • Strong organizational and time management skills with a proven ability to work effectively in fast-paced environments.
  • Excellent attention to detail, especially when reviewing and preparing regulatory documentation.


The position is to be based in Cheshire, with a high flexibility on working from home.


Do you think this job fits your profile? Apply now and we will be in touch quickly to give you more insight on the position and give you more insight on our client

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