Product Lifecycle Manager – Medical Device

About the role

As a Product Lifecycle Manager you will ensure that our medical device portfolio stays regulatory‑compliant, safe and future‑proof throughout its entire lifecycle. You will coordinate design and change processes, keep technical documentation up to date and balance regulatory, quality and business requirements while working closely with R&D, Quality, Regulatory Affairs and Operations.

Key responsibilities

• Manage product and design changes across the lifecycle, including project management and creation of regulatory‑compliant documentation (EN ISO 13485, EU‑MDR, 21 CFR 820, MDSAP).
• Maintain and develop Design History Files (DHF) and technical documentation for Class Is/m to IIa/b devices.
• Ensure traceability from user needs through design inputs/outputs, verification, validation and risk management.
• Act as the technical point of contact for Design Control & Lifecycle Management for all stakeholders.
• Support quality activities such as risk management (EN ISO 14971), CAPAs, complaints, non‑conformances and post‑market topics.
• Plan and support transfer of new developments and product changes into production.
• Participate in design reviews as an independent reviewer focusing on lifecycle and compliance aspects.
• Assist audits and inspections and contribute to continuous improvement of lifecycle management processes.

Required profile

• Bachelor’s degree in a technical or scientific field (engineering, medical technology, life sciences, etc.); master’s degree is a plus.
• Minimum 3 years of experience in the medical device or life‑science industry, preferably in product lifecycle management or quality‑regulated functions.
• Proven experience managing complex, cross‑functional projects with multiple stakeholders.
• Practical knowledge of regulated environments (EN ISO 13485, EU‑MDR, 21 CFR 820, MDSAP, ISO 14971, IEC 62366).
• Fluent English (C1) and German (B1) language skills.
• Strong analytical, structured and solution‑oriented working style with high initiative and reliability.

Required skills

• Regulatory standards: EN ISO 13485, EU‑MDR, 21 CFR 820, MDSAP, EN ISO 14971, IEC 62366.
• MS Office 365.

What we offer

• Secure, responsible position within an international team.
• Welcoming culture with structured onboarding and a friendly working atmosphere.
• Opportunities for idea management, process shaping and independent work.
• Professional and personal development through internal and external training.
• Flexible working time models, flexitime and up to two days per week of mobile working.
• Company events, free parking and other employee benefits.