Medical Affairs Manager (Medical Devices)

Location: Berlin, Germany

Company

hirify.global develops precision components and subsystems for healthcare and advanced manufacturing, including medical technologies for minimally invasive surgery.

What you will do

• Prepare and update Post-Market Surveillance Plans and Reports, Periodic Safety Update Reports, PMCF documentation, and Clinical Evaluation Plans and Reports.
• Maintain documentation in an audit-ready condition and support Medical Affairs processes including risk management, change management, and CAPA.
• Conduct scientific literature and vigilance searches, evaluations, and reviews in accordance with MDR/MEDDEV requirements.
• Plan CE-registration studies and PMCF studies in accordance with ISO 14155.
• Collaborate with Regulatory Affairs, Product Management, R&D, and external service providers on clinical and post-market documentation.
• Conduct annual PMCF surveys in hospital environments and attend professional conferences to build clinical experience.

Requirements

• University degree in life sciences, natural sciences, or an equivalent field; a PhD is advantageous.
• Professional experience in the medical device industry or a similar field, with a basic understanding of Medical Affairs processes.
• Expertise in medical writing, including literature and vigilance searches, evaluation, review, and database management.
• 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. German language skills are advantageous.

Nice to have

• Knowledge of clinical indications and applications in minimally invasive surgery.
• Experience with medical device clinical investigations or the pharmaceutical industry.
• Familiarity with AI tools.

Culture & Benefits

• Work within the Advanced Surgery business unit on solutions designed to improve medical system performance and patient outcomes.
• Collaborate across Regulatory Affairs, Product Management, R&D, hospitals, and external service providers.
• Travel by public transportation, train, or airplane as required for fairs, conferences, customer meetings, and operating-room visits.
• An international passport is required for business travel.
• Follow quality, occupational safety, and environmental regulations.