Manager of Clinical Assessments

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 enhancing healthcare outcomes through innovation and support. We empower healthcare professionals to focus on what truly matters: making a positive impact on patients' lives. Your commitment will enable you to grow and thrive in your role.

Position Overview:
As a Clinical Evaluation Manager, you will be part of a dynamic global team. This role offers a diverse and stimulating opportunity within an international setting, where you can enhance your expertise and actively contribute to the compliance of medical devices with clinical performance and safety standards.

Key Responsibilities:
  • Maintain and update documentation related to clinical evaluations, post-market clinical follow-ups, and post-marketing surveillance.
  • Facilitate cross-departmental communication with teams such as Marketing and Research & Development to ensure that necessary documentation is current.
  • Coordinate with external service providers to assist in clinical evaluation documentation, PMCF, and PMS activities.
  • Identify clinical evidence requirements in accordance with MDR and relevant MDCGs.
  • Conduct literature searches and reviews as per MDR/MEDDEV 2.7.1 rev. 4, and perform searches in relevant vigilance databases.
  • Support risk analysis and study planning for CE and PMCF studies.

Qualifications:
  • A university degree in life sciences, natural sciences, or a related field.
  • Professional experience in the medical device sector or a related regulatory environment.
  • Familiarity with regulatory requirements, including MDR and relevant MDCGs.
  • Experience in literature searches and reviews, along with knowledge of regulatory medical writing.
  • Proficiency in database management and a competent approach to stakeholder engagement.
  • Strong IT skills, particularly with the MS Office suite.
  • Fluency in written and spoken English.

Benefits:
  • Flexible working arrangements, including adaptable hours and remote work options.
  • Support for work-life balance, including childcare subsidies.
  • 30 days of paid leave annually, along with special leave for significant life events.
  • Company pension plan with attractive employer contributions.
  • Access to fitness and wellness programs, including skin cancer screenings and mental health courses.
  • Job Bike Leasing and discounts on travel, fashion, and technology through our corporate benefits platform.

Shape a career that prioritizes healthcare customers and fosters a culture of trust and openness.

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