Clinical Compliance Manager

vor 3 Wochen

Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

Join Our Team at PAUL HARTMANN AG

At PAUL HARTMANN AG, we are dedicated to supporting healthcare professionals in their mission to enhance patient care. Our commitment to innovation and quality drives us to develop solutions that truly make a difference in people's lives.

Your Role

As a Clinical Evaluation Manager, you will play a crucial role in our international team. This position offers a diverse and stimulating environment where you can enhance your expertise while ensuring compliance with clinical performance and safety standards for medical devices.

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 R&D to ensure all necessary documentation is current.
  • Oversee external service providers to assist with clinical evaluation documentation, PMCF, and PMS.
  • Define clinical evidence requirements in accordance with MDR and relevant MDCGs.
  • Assess equivalence to existing devices as needed, following MDRs and relevant MDCGs.
  • Conduct comprehensive literature searches and reviews in compliance with MDR/MEDDEV 2.7.1 rev. 4.
  • Utilize relevant vigilance databases for necessary searches.
  • Support risk analysis and study planning for CE and PMCF studies.

Qualifications:

  • A university degree in life sciences, natural sciences, or a related field.
  • Experience in the medical device sector or a similar regulatory environment.
  • Familiarity with regulatory requirements, including MDR and relevant MDCGs, as well as MEDDEVs.
  • Proficient in literature search and review, with a solid understanding of regulatory medical writing.
  • Knowledge of database management practices.
  • A collaborative and professional approach when engaging with stakeholders.
  • Strong IT skills, particularly with the MS Office suite.
  • Fluency in written and spoken English.

What We Offer:

  • Flexible working arrangements, including adaptable hours and remote work options.
  • International opportunities for mobile working.
  • Supportive measures for balancing work and family life, such as childcare subsidies.
  • Generous leave policies, including 30 days of paid vacation and additional leave for significant life events.
  • A comprehensive company pension plan with attractive employer contributions.
  • Convenient amenities, including ample parking and an on-site canteen.
  • Access to a wide range of fitness and wellness facilities.
  • Various health initiatives, including screenings and mental health resources.
  • Job bike leasing options.
  • Exclusive discounts on travel, fashion, and technology through our corporate benefits platform.

Shape your career with us, focusing on healthcare innovation and fostering a culture of trust and openness.

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