Senior QARA Lead, Medical Devices & Global Submissions

Excelya; Dijon; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Excelya in Dijon, France, seeks a senior Regulatory Affairs professional to lead regulatory strategies across devices and life sciences. You will ensure compliance during design and development, steer quality processes, and collaborate with cross-functional teams to drive global submissions.

The role emphasizes experience with Class II medical devices, ISO13485, and lifecycle management, offering a path to shape regulatory excellence within a dynamic CRO environment.

Qualifications

• Master's degree in life sciences, pharmacy, chemistry, or a related field.
• Proven experience in Regulatory Affairs within pharma/biotech/medical devices, including global submissions and lifecycle management.
• At least 10 years of QARA experience within the medical device field.
• Significant experience with Class II medical devices.

Responsabilités

• Maintain and improve the Quality Management System (ISO 13485 compliant).
• Ensure regulatory compliance throughout product design and development with project teams.
• Oversee Design Control, risk management, and technical documentation activities.
• Define and implement the Quality and Regulatory Affairs strategy.
• Plan and manage internal and external audits.
• Develop, review, and optimize quality processes, procedures, and documentation.
• Manage product technical files and act as key contact for regulatory authorities.
• Monitor EU & US regulatory changes and support FDA requirements.

Connaissances

Regulatory knowledge

Quality systems

Stakeholder management

Communication skills

Organizational skills

Formation

Master's degree in life sciences

Description du poste

Excelya in Dijon, France, seeks a senior Regulatory Affairs professional to lead regulatory strategies across devices and life sciences. You will ensure compliance during design and development, steer quality processes, and collaborate with cross-functional teams to drive global submissions.

The role emphasizes experience with Class II medical devices, ISO13485, and lifecycle management, offering a path to shape regulatory excellence within a dynamic CRO environment.