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Head of Vigilance

4 weeks ago

UK, UK, United Kingdom Sinclair Full time

About Sinclair

At Sinclair, our people are the cornerstone of our success. We are driven by a commitment to excellence, mirroring our industry-leading products and values. Self-owned and motivated, our passionate team fuels our mission to create confidence—confidence in our products, for our customers, and within ourselves. Founded in 1971, Sinclair is a global medical aesthetics organization offering an extensive range of products, from injectable fillers for the body to advanced medical devices for hair removal, fat sculpting, and skin rejuvenation. With a comprehensive in-house commercial infrastructure, including manufacturing and a global distributor network, our products are sold in over 55 countries worldwide.


Job Overview

The Head of Vigilance will oversee and support the vigilance team in managing the safety profile of all Sinclair products, including those under clinical trials, and ensure compliance throughout all phases of development and commercialization.

This leader will manage a team of safety specialists responsible for regulatory reporting and medical monitoring, ensuring adherence to global and regional requirements. Additionally, the role involves driving initiatives to enhance quality and efficiency within the safety department, maintaining high safety standards, and promoting continuous improvement.



Key Responsibilities

  • Safety Surveillance and Compliance:
  • Organize, manage, and maintain a robust and compliant safety surveillance system.
  • Ensure adherence to local and global processes, guidelines, and regulations for medical device safety.
  • Maintain 24/7 safety business continuity and after-hours availability.
  • Regulatory and Audit Management:
  • Lead and coordinate internal and external safety audits and inspections.
  • Monitor the performance and compliance of partners and distributors with safety regulations.
  • Legislative Awareness and Expertise:
  • Maintain expertise in national and international regulatory environments and promote awareness of legislative changes.
  • Ensure internal regulatory and pharmacovigilance (PV) processes are well-documented and support compliant activities.
  • Strategic Leadership:
  • Oversee all strategic safety surveillance activities, ensuring complete and accurate maintenance and reporting of Medical Device Reports (MDRs), adverse reactions, and compliance with global regulatory requirements.
  • Act as a liaison between internal and external stakeholders to develop programs and processes to meet regulatory reporting standards.


Experience and Qualifications:


Essential:

  • Minimum of 5 years’ experience in safety and complaint management within a medical device or aesthetics organization.
  • In-depth knowledge of the Medical Device Regulation (MDR) and 21 CFR Part 803, 820.
  • Familiarity with global regulatory requirements and compliance frameworks.


Desirable:

  • A university degree in a scientific field.
  • Proven experience leading teams in regulated environments, supporting complaint handling, engineering, or operational functions.
  • Specific expertise in dermatology or aesthetics.


Why Join Sinclair?

At Sinclair, you’ll work with a team that’s as innovative as the products we create. Join us on our journey to becoming a global leader in medical aesthetics. This role offers an exciting opportunity to make a significant impact in a rapidly growing, cutting-edge industry. If you’re driven, knowledgeable, and ready to lead, we want to hear from you.