Clinical Evaluation Manager (f/m/d)

At HARTMANN, we’re all in to help, care, protect, and grow. We support healthcare professionals so they can focus on what really matters: positively impacting people’s lives. We realize solutions that make a difference. With your commitment, you can grow in your job every day. At HARTMANN, we believe in the difference you can make.

Join our team as

Clinical Evaluation Manager (f/m/d)

As a Manager Regulatory Affairs Clinical (f/m/d), we offer you a varied and challenging position in an international environment. Here, you can develop your skills and play an active role in ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements. If you are also enthusiastic about our meaningful product portfolio, we should get to know each other.

Responsibilities:

• Provide and update documentation of clinical evaluation, post-market clinical follow-up, and post-marketing surveillance.
• Cross-functional communication with other departments such as Marketing and R&D to ensure required input documentation is up to date.
• Coordinate external service providers to support clinical evaluation documentation, PMCF, and PMS.
• Determine clinical evidence requirements according to MDR and relevant MDCGs.
• Identify equivalence to existing devices, if required, in accordance with MDRs and relevant MDCGs.
• Conduct literature searches and reviews in accordance with MDR/MEDDEV 2.7.1 rev. 4.
• Provide searches in relevant vigilance databases.
• Support for risk analysis and study planning for CE and PMCF studies.

Qualification:

• University degree in life science/natural science or an equivalent qualification.
• Professional experience in the medical device environment or another regulatory field of work.
• Knowledge in regulatory requirements, MDR, and relevant MDCGs.
• Experience in literature search and review required as well as knowledge of regulatory medical writing.
• Knowledge of database management.
• Open and competent attitude when working with your stakeholders.
• IT affinity and proficiency with the MS Office package.
• Fluent written and spoken English.

Shape a career that’s focused on healthcare customers, fit for the future, and grounded in a culture of trust and openness. Apply now via our online platform.