Quality Systems & Regulatory Compliance Manager

About the role

As the Quality Systems and Regulatory Compliance Manager you will safeguard the integrity of the Quality Management System across UK manufacturing sites, ensuring compliance with all applicable medical‑device standards and regulations.

Key responsibilities

• Lead the Quality Systems team and the Document Control/eQMS team.
• Coordinate and improve internal quality processes, including CAPA, internal audits, management reviews and document control.
• Track quality system performance using KPIs and report results to senior management.
• Manage the Regulatory Compliance team and lead external audits from notified bodies, customers or other regulators.
• Support regulatory affairs submissions for product and facility registrations and communicate manufacturing changes.
• Act as Management Representative for UK manufacturing sites and liaise with other UK and international representatives.
• Ensure all quality‑system processes are documented and that awareness of regulatory requirements is communicated organization‑wide.

Required profile

• Proven experience managing quality systems in a medical‑device environment.
• Strong knowledge of applicable standards and regulations (e.g., ISO 13485, MDR).
• Demonstrated ability to lead cross‑functional teams and coordinate audits.
• Willingness to travel between UK sites as needed.

Required skills

• eQMS implementation and management
• CAPA management
• Document control systems

What we offer

• Competitive salary and benefits package
• Opportunity to work for a global leader in soft contact lenses
• Professional development in a regulated industry