Medical Affairs Manager Medical Devices (m/f/d)

Location: Berlin, Germany

Company

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

What you will do

• Prepare and maintain Post-Market Surveillance Plans and Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up documentation, and Clinical Evaluation Plans and Reports.
• Keep regulatory and clinical documentation current and audit-ready for products in development, new products, and legacy products.
• Support Medical Affairs processes including post-market surveillance, PMCF, clinical evaluation, risk management, change management, and CAPA documentation.
• Conduct scientific literature and vigilance searches, evaluations, and reviews in accordance with MDR/MEDDEV requirements.
• Plan CE-registration studies and PMCF studies according to ISO 14155.
• Collaborate with Regulatory Affairs, Product Management, R&D, and external service providers, including participation in hospital surveys and professional conferences.

Requirements

• University degree in life sciences, natural sciences, or an equivalent field; a PhD is an advantage.
• Professional experience in the medical device industry or a similar field, with a basic understanding of Medical Affairs processes.
• Expertise in medical writing, literature and vigilance searches, evaluation and review, and database management.
• Demonstrated experience creating, editing, and proofreading Clinical Evaluation Plans and Reports, including PRISMA and PICO analysis.
• Knowledge of MDR, relevant MDCGs, MEDDEV, ISO 13485, ISO 14971, FDA QSR, and ISO 14155.
• Fluent written and spoken English at C1 level or higher is required. Strong attention to detail, stakeholder competence, and proficiency with Microsoft Office are also required.

Nice to have

• PhD in a relevant discipline.
• Knowledge of clinical indications and applications in minimally invasive surgery.
• Experience in medical device clinical investigations or the pharmaceutical industry.
• German language skills.
• Familiarity with AI tools.

Culture & Benefits

• Full-time position within hirify.global’s Advanced Surgery business unit.
• Work involves collaboration across Regulatory Affairs, Product Management, R&D, and external service providers.
• Travel by public transportation, train, and airplane may be required for fairs, conferences, customer and internal meetings, and operating-room visits.
• A passport for international business travel is required.
• Compliance with quality, occupational safety, and environmental regulations is expected.