Senior Regulatory Affairs Lead – Medical Devices

Excelya; Dijon; In loco; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Excelya is seeking a Regulatory Affairs Manager to lead strategic regulatory initiatives and drive regulatory excellence across global submissions and lifecycle management. The role collaborates with QA, R&D, Clinical, Manufacturing, and Marketing to ensure compliance and timely market access.

The ideal candidate has deep expertise in MDR/IVDR, ISO standards, and a track record of cross-functional collaboration in medical devices or pharma settings.

Competenze

• Education: Master's degree in life sciences, pharmacy, chemistry, or a related field.
• Experience: Proven Regulatory Affairs experience in pharma/biotech/medical device with global submissions and lifecycle management.
• Significant experience with Class II medical devices and QARA responsibilities.

Mansioni

• Develop and implement regulatory strategies to support product development, registration, and market access activities.
• Prepare, maintain, and update Technical Documentation per MDR 2017/745 requirements.
• Coordinate CE Marking activities.
• Assess regulatory impact of product changes across the lifecycle.
• Ensure compliance with MDR 2017/745, ISO 13485, ISO 14971.
• Support PMS, Vigilance, PMCF activities.
• Participate in audits, inspections, and regulatory assessments.
• Interface with Competent Authorities and external regulatory partners.
• Monitor regulatory developments and communicate impacts to stakeholders.
• Collaborate with QA, R&D, Clinical, Manufacturing, and Marketing for compliance.
• Provide regulatory guidance and training to cross-functional teams.

Conoscenze

Regulatory strategy

Global submissions

Cross-functional collaboration

Stakeholder management

Quality systems

Regulatory requirements

Formazione

Master's degree in life sciences/related field

Descrizione del lavoro

Excelya is seeking a Regulatory Affairs Manager to lead strategic regulatory initiatives and drive regulatory excellence across global submissions and lifecycle management. The role collaborates with QA, R&D, Clinical, Manufacturing, and Marketing to ensure compliance and timely market access.

The ideal candidate has deep expertise in MDR/IVDR, ISO standards, and a track record of cross-functional collaboration in medical devices or pharma settings.