Medical Affairs Manager (Medtech)

TL;DR

Medical Affairs Manager (Medtech): Ensuring regulatory compliance and clinical performance documentation for medical devices with an accent on MDR/MEDDEV standards and clinical evaluation reports. Focus on managing Post Market Surveillance, conducting scientific literature reviews, and collaborating with cross-functional teams to maintain audit-ready 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

• Prepare and update regulatory documentation including PMS, PSUR, and PMCF reports.
• Conduct scientific literature searches and clinical evaluations according to MDR/MEDDEV 2.7.1.
• Plan and execute clinical studies for CE-registrations in compliance with ISO 14155.
• Collaborate with Regulatory Affairs, R&D, and Product Management to ensure documentation quality.
• Perform annual PMCF surveys in hospital environments and participate in professional conferences.
• Maintain audit-ready documentation for legacy and new products.

Requirements

• University degree in life science or natural science required.
• Professional experience in the medical device industry required.
• Expert knowledge in medical writing and clinical evaluation plans required.
• Fluent English (C1+) required.
• Knowledge of MDR, ISO 13485, ISO 14971, and ISO 14155 required.
• Must be based in Berlin, Germany.

Nice to have

• PhD degree.
• Knowledge of clinical indications in Minimally Invasive Surgery.
• German language skills.
• Familiarity with AI tools.

Culture & Benefits

• Global team environment with over 26 offices worldwide.
• Culture focused on teamwork, collaboration, and empowerment.
• Opportunities to attend international congresses and conferences.
• Equal employment opportunity workplace.