Regulatory Quality Affairs Specialist – Medical Devices

About the role

We are seeking a Regulatory Quality Affairs Specialist to lead regulatory and quality activities for ophthalmic medical devices, from concept through market launch and post‑market support. The role ensures compliance with EU MDR, CE marking, and ISO 13485 while supporting product development and lifecycle management.

Key responsibilities

• Manage and maintain technical documentation and regulatory dossiers, including submissions, registrations and responses to Competent Authorities and Notified Bodies.
• Support compliance with EU MDR, CE marking, EUDAMED, ISO 13485, vigilance and post‑market surveillance requirements.
• Participate in the development of new ophthalmic devices, coordinating product testing, stability, compatibility and performance studies.
• Contribute to risk management, design verification and validation, ensuring outputs are reflected in technical documentation.
• Support product modifications, improvements and lifecycle management of existing devices.
• Maintain and improve the ISO 13485 Quality Management System, handling procedures, CAPAs, non‑conformities, supplier qualification and audits.
• Review and approve labeling, IFUs, packaging and related documentation from a regulatory perspective.
• Perform regulatory and technical gap analyses and monitor changes in applicable regulations and standards.

Required profile

• Degree in Pharmacy, Life Sciences, Biomedical Engineering, Biotechnology, Chemistry, Medical Devices or a related scientific/technical discipline.
• 3‑5 years of experience in regulatory affairs, quality, and/or product development within the medical device or related healthcare industry.
• Strong knowledge of EU MDR, ISO 13485, CE marking and medical‑device technical documentation.
• Practical experience with product development, technical documentation and risk management.

Required skills

• Regulatory affairs expertise (EU MDR, CE marking)
• ISO 13485 compliance and quality management
• Medical‑device technical documentation preparation
• Risk management and design verification/validation
• CAPA and audit support
• Labeling and IFU review
• Regulatory gap analysis and standards monitoring