Clinical Affairs Manager

vor 3 Wochen

Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit
Join Our Team as a Clinical Evaluation Manager

At PAUL HARTMANN AG, we are dedicated to supporting healthcare professionals in their mission to enhance patient care. We believe in the power of your contributions to make a meaningful impact on lives. As a Clinical Evaluation Manager, you will be part of a dynamic global team, where your expertise will play a crucial role in our commitment to quality and compliance.

Key Responsibilities:
  • Develop and maintain comprehensive documentation for clinical evaluations, post-market clinical follow-ups, and post-marketing surveillance.
  • Facilitate cross-departmental collaboration with teams such as Marketing and Research & Development to ensure all necessary documentation is current.
  • Coordinate with external service providers to support clinical evaluation documentation, PMCF, and PMS activities.
  • Assess clinical evidence requirements in accordance with the Medical Device Regulation (MDR) and relevant MDCGs.
  • Conduct thorough literature searches and reviews in compliance with MDR/MEDDEV 2.7.1 rev. 4.
  • Provide insights from vigilance databases and support risk analysis and study planning for CE and PMCF studies.

Qualifications:
  • A degree in life sciences, natural sciences, or a related field.
  • Professional experience in the medical device sector or a similar regulatory environment.
  • Strong understanding of regulatory requirements, including MDR and relevant MDCGs.
  • Proficiency in literature search and review processes, along with regulatory medical writing skills.
  • Familiarity with database management and a collaborative approach to stakeholder engagement.
  • Proficient in MS Office and fluent in written and spoken English.

What We Offer:
  • Flexible working arrangements, including adaptable hours and remote work options.
  • 30 days of paid leave annually, plus additional leave for significant life events.
  • Company pension plan with attractive employer contributions.
  • Access to fitness and wellness programs, including yoga and mental health resources.
  • Discounts on travel, fashion, and technology through our corporate benefits platform.

Shape a career focused on healthcare excellence and join us in making a difference.

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