Manager Regulatory Affairs (Medical Devices)

Location: Berlin, Germany

Company

hirify.global develops engineered components, subsystems, and medical technology for healthcare, advanced manufacturing, minimally invasive surgery, robotics, and 3D metal printing.

What you will do

• Lead regulatory submissions and approvals for medical devices, including free sales certificates, legalizations, declarations, and other certification documents.
• Coordinate documentation for notified bodies and competent authorities worldwide.
• Control technical documentation, assess conformity with essential requirements, and prepare declarations of conformity.
• Manage interfaces with customer regulatory teams, notified bodies, authorities, suppliers, and external partners.
• Support customer, authority, and supplier audits in cooperation with the quality management representative.
• Manage safety-related complaints and initiate quality-management and process-improvement measures.

Requirements

• 8–12 years of extensive professional experience in regulatory affairs, preferably including management experience.
• Completed degree in natural sciences, engineering, medicine, or a comparable field.
• Extensive regulatory affairs expertise with a specialized background in the medical device industry.
• Advanced training as a Manager Regulatory Affairs for Medical Devices.
• English at CEFR C1 and German at CEFR B2 are required.
• Structured, independent, quality-oriented, reliable, and effective in communicating with internal and external stakeholders.

Culture & Benefits

• Full-time management position within the Advanced Surgery business unit.
• Responsibility for team leadership, employee development, resource planning, and budget planning.
• Collaboration with customers, doctors, technical experts, regulatory agencies, and cross-functional teams.
• Willingness to travel to hirify.global locations and business partners for up to 10% of working time.
• Commitment to quality, occupational safety, environmental protection, and equal employment opportunity.