Medical Affairs Manager (Medical Devices)

TL;DR

Medical Affairs Manager (Medical Devices): Ensuring product compliance with clinical performance and safety regulations for advanced surgery technologies with an accent on MDR/MEDDEV documentation and clinical evaluation. Focus on managing Post Market Surveillance (PMS), PMCF studies, and maintaining audit-ready clinical documentation.

Location: Berlin, Germany (Onsite)

Company

hirify.global is a global leader in precision engineered components and sub-systems for mission-critical applications in healthcare and advanced manufacturing.

What you will do

• Manage and update regulatory documentation including PMS, PSUR, PMCF, and Clinical Evaluation Plans/Reports.
• Conduct scientific literature reviews and vigilance searches in accordance with MDR/MEDDEV 2.7.1 rev. 4.
• Plan and execute clinical studies for CE-registrations and PMCF in compliance with ISO 14155.
• Collaborate with Regulatory Affairs, R&D, and Product Management to ensure documentation integrity.
• Perform annual PMCF surveys in hospital environments and participate in professional conferences.
• Ensure strict compliance with quality, safety, and environmental regulations.

Requirements

• University degree (Master/Diploma) in life science or natural science.
• Professional experience in the medical device industry.
• Expert knowledge in medical writing and clinical evaluation (PRISMA & PICO analysis).
• Strong understanding of regulatory standards (MDR, ISO 13485, ISO 14971, ISO 14155).
• Fluent English (C1 minimum) is required.
• Must be based in or able to work from Berlin, Germany.

Nice to have

• PhD in a relevant field.
• Knowledge of clinical indications in Minimally Invasive Surgery.
• Experience with AI tools.
• German language skills.

Culture & Benefits

• Global team environment with over 26 offices worldwide.
• Culture focused on teamwork, collaboration, and empowerment.
• Opportunities to work on innovative, mission-critical medical technologies.
• Support for professional development and industry networking.