Regulatory Compliance Manager

About the role

CooperVision is seeking an experienced Regulatory Compliance Manager to lead the implementation and monitoring of its Quality Management System across the manufacturing site. The role ensures compliance with global regulatory requirements, supports product and plant registrations, and drives continuous improvement of quality processes.

Key responsibilities

• Implement and monitor the Quality Management System (QMS) and ensure alignment with GMP, ISO 13485, 21 CFR 820, EU MDR and MDSAP standards.
• Support regulatory decisions, product and plant registrations, and device listings.
• Lead internal and external audits, manage customer complaints, and oversee the Quality Feedback subsystem.
• Conduct management review activities, document and change control, and risk management processes.
• Review and approve NCRs, CAPAs, QFBs, and other quality documentation.
• Identify, trace, and periodically review regulatory requirements.
• Provide training on regulatory compliance, GMP, and GDP.
• Lead site quality and compliance culture programs and improvement initiatives.

Required profile

• Minimum five years of experience in regulatory compliance or quality management within a regulated manufacturing environment.
• Strong knowledge of GMP/QSR, ISO 13485, 21 CFR 820, EU MDR, QMS and MDSAP.
• Excellent oral and written communication skills in English; Spanish is a plus.
• Proven ability to manage multiple tasks, work under pressure, and lead cross‑functional teams.

Required skills

• GMP/QSR knowledge
• ISO 13485
• 21 CFR 820
• EU MDR
• MDSAP
• Microsoft Office (Word, PowerPoint, Excel)