Senior Regulatory Affairs Lead - Medical Devices

PharmaLex; Madrid; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Cencora is hiring a Senior Manager, Regulatory Affairs - Medical Device to lead regulatory development strategy across medical device projects. You will guide teams, manage client relationships, and ensure timely, quality regulatory deliverables for health authorities and clients in diagnostics and drug-device segments.

The role emphasizes senior leadership, expert regulatory input, and collaboration with Health Authorities, clients, and internal teams to drive business growth and compliance

Qualifications

• Proven experience in regulatory affairs for medical devices or drug-device combos.
• Strong knowledge of medical technology and veterinary products.
• Experience supporting medical advice activities and regulatory submissions.

Responsabilités

• Lead client projects aligning with KPIs, timelines, budgets and quality.
• Coordinate internal and external teams for effective delivery.
• Provide regulatory consultancy and strategic input to clients and colleagues.
• Engage with Health Authorities and support regulatory procedures.
• Contribute to business development and capability building.

Connaissances

Regulatory affairs

Medical devices

Project leadership

Client management

Regulatory strategy

Compliance

Communication skills

English (fluent)

Formation

University degree in Science or Engineering

Description du poste

Cencora is hiring a Senior Manager, Regulatory Affairs - Medical Device to lead regulatory development strategy across medical device projects. You will guide teams, manage client relationships, and ensure timely, quality regulatory deliverables for health authorities and clients in diagnostics and drug-device segments.

The role emphasizes senior leadership, expert regulatory input, and collaboration with Health Authorities, clients, and internal teams to drive business growth and compliance