Clinical Affairs Manager (m/f/d) (Specialist Lawyer - Medical Law)

For our client, one of the world's largest providers and manufacturers in the field of medical technology, we are looking for you!

Your Tasks

• In your role, you plan and coordinate PMCF and clinical evaluation activities across the entire product portfolio to ensure the conformity of our medical devices with the EU Medical Device Regulation (MDR) and to provide robust and scientifically sound evidence of safety, performance, and clinical benefit.
• In close cooperation with product lines, Regulatory Affairs, Marketing, and Research & Development, you evaluate the need for additional clinical data collection after market launch from medical, economic, and regulatory perspectives. You develop strategies for generating, analyzing, and utilizing PMCF data to confirm and further develop clinical claims. Furthermore, you support the implementation of PMCF activities.
• With the support of relevant stakeholders, you create and maintain PMCF plans and PMCF reports to evaluate clinical data from Post-Market Surveillance, clinical trials, and scientific literature.
• Together with the Clinical Affairs Manager, you support the creation of clinical evaluation documentation with a special focus on integrating data from preclinical and non-clinical tests, clinical trials, and clinical development activities.
• You work closely with internal stakeholders, for example from Product Management, Research & Development, Regulatory Affairs, and external partners, for example in the field of Medical Writing, and ensure effective cross-functional coordination.

Your Profile

• You have a completed degree in medicine, natural sciences, or engineering.
• You have many years of professional experience and a deep understanding of the regulations and laws for clinical activities, including the EU-MDR and the MDCG guidelines. Additional knowledge of frameworks in China and USA is an advantage.
• You possess relevant expertise and practical experience in designing processes that meet the requirements of EU Clinical Lifecycle Management and clinical evaluation.
• Preferably, you are familiar with magnetic resonance technology in clinical practice.
• You possess a fundamental understanding of clinical research methods, including clinical trial design, biostatistics, and information management.
• You have strong presentation and communication skills as well as business-fluent English skills that enable you to communicate easily and at eye level with different business areas, cultures, and management levels in an international environment. German skills are an advantage.
• You understand the intention of regulatory and legal requirements and can translate them into effective and compliant operational processes.
• On a personal level, your profile is rounded off by decision-making ability, the ability to analyze and communicate complex issues, and the structured, reliable, and goal-oriented processing of tasks.
• We win together: You are an absolute team player and enjoy implementing our high standards within the team.

What We Offer You

• Above-tariff compensation including attractive bonuses
• Awards that speak for themselves - including Kununu Top Company 2026 and FOCUS Top National Employer 2026
• Personal support by a fixed contact person throughout the entire assignment
• Increasing holiday and Christmas bonuses within the first four years of employment
• Employee-refer-employee bonus of up to 1,000 EUR
• Company pension scheme for your financial future
• Flexible working hours through a personal flextime account
• Individual training and development opportunities
• Very good chances of permanent employment with our client
• Depending on the area of assignment, there is the possibility of working from home in coordination with our client

Does this sound like an exciting task for you? Then we look forward to receiving your application! Please send us your complete application documents, stating your salary expectations and your possible starting date, via e-mail, post, or directly through our career portal.

You can find more information about us at www.tintschl.de or free of charge at 0800 898 898 0.

This is Tintschl

The Tintschl Group, headquartered in Erlangen, has stood for premium service expertise in the areas of Personnel, Engineering, and IT since 1997. Our employees are specialized in implementing technically and organizationally demanding projects for our customers located throughout Germany.

Equal opportunity is an essential part of our corporate culture as an employer and the key to a diverse and inclusive working world. We promote diversity, inclusion, the compatibility of work and family, and equal opportunities for all people.

Find the perfect job with us and apply.

We look forward to welcoming you.