Clinical Evaluation Manager

vor 2 Wochen

Ulm, Baden-Württemberg, Deutschland HARTMANN Vollzeit

About HARTMANN

HARTMANN is a global healthcare company committed to helping, caring, protecting, and growing to positively impact people's lives. As a leading provider of medical devices and solutions, we strive to make a difference in the lives of our customers and patients.

Job Summary

We are seeking a highly skilled Clinical Evaluation Manager to join our Regulatory Affairs team. As a key member of our team, you will be responsible for providing and updating clinical evaluation documentation, coordinating external service providers, and ensuring medical device compliance with regulatory requirements.

Key Responsibilities

  • Provide and update clinical evaluation documentation to support regulatory submissions and product launches.
  • Coordinate with external service providers to ensure timely and high-quality delivery of clinical evaluation services.
  • Determine clinical evidence requirements for medical devices and develop strategies to meet these requirements.
  • Conduct literature searches and reviews to stay up-to-date on the latest clinical evidence and regulatory requirements.
  • Support risk analysis and study planning to ensure compliance with regulatory requirements.

Qualifications

  • University degree in life science or natural science.
  • Experience in the medical device environment, preferably in a regulatory affairs role.
  • Knowledge of regulatory requirements and guidelines, including those related to clinical evaluation and medical devices.
  • Experience in literature search and review, as well as risk analysis and study planning.
  • IT proficiency with MS Office package.

What We Offer

  • Flexible working conditions and a dynamic work environment.
  • A company pension plan and other benefits to support your well-being.
  • Opportunities for professional growth and development in a global healthcare company.

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