Manager - Regulatory Compliance

About the role

The Manager – Regulatory Compliance is responsible for implementing and monitoring the Quality Management System, ensuring that all regulatory requirements for products, plants and devices are met. This role supports regulatory decisions, product and plant registrations, and drives a culture of compliance across the site.

Key responsibilities

• Implement and monitor the Quality Management System (QMS) and support regulatory decisions.
• Manage internal and external audits, customer complaints, and the Quality Feedback (QFB) subsystem.
• Lead management review activities, document and change control, and risk management processes.
• Review and approve NCRs, CAPAs, QFBs, customer complaints and other quality documentation.
• Identify, trace, and periodically review regulatory requirements (GMP, ISO13485, 21 CFR 820, EU MDR, MDSAP).
• Monitor quality system indicators and perform revisions of global and local procedures.
• Provide training on QMS regulations, internal audits, GMP and GDP.
• Lead site quality and compliance culture programs and improvement initiatives.
• Ensure compliance with laws, regulations, CooperVision values, and safety/health policies.

Required profile

• Strong knowledge of GMPs/QSR and medical‑device regulations (ISO 13485, 21 CFR 820, EU MDR, MDSAP).
• Excellent oral and written communication skills in English and Spanish.
• Service‑oriented attitude with strong organizational abilities.
• Ability to manage multiple tasks, work under pressure and collaborate in a team environment.
• Effective people‑management skills and a commitment to professional development.

Required skills

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