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Clinical Compliance Manager
vor 3 Monaten
About Us: At PAUL HARTMANN AG, we are dedicated to supporting healthcare professionals in their mission to enhance the quality of life for individuals. Our commitment to innovation drives us to develop solutions that truly make a difference.
Position Overview: We invite you to join our dynamic team as a Clinical Evaluation Manager. This role offers a unique opportunity to engage in a diverse and stimulating environment where you can further develop your expertise while contributing to the compliance of medical devices with clinical performance and safety standards.
Key Responsibilities:
- Maintain and enhance documentation related to clinical evaluations, post-market clinical follow-ups, and post-marketing surveillance.
- Facilitate cross-departmental collaboration with teams such as Marketing and R&D to ensure that all necessary documentation is current and comprehensive.
- Oversee the coordination of external partners to assist in the preparation of clinical evaluation documentation, PMCF, and PMS.
- Establish clinical evidence requirements in accordance with the Medical Device Regulation (MDR) and relevant Medical Device Coordination Group (MDCG) guidelines.
- Assess equivalence to existing devices when necessary, following MDRs and relevant MDCGs.
- Conduct thorough literature searches and reviews in compliance with MDR/MEDDEV 2.7.1 rev. 4.
- Perform searches in pertinent vigilance databases.
- Assist in risk analysis and study planning for CE and PMCF studies.
Qualifications:
- A degree in life sciences, natural sciences, or a related field.
- Experience in the medical device sector or a similar regulatory environment.
- Strong understanding of regulatory requirements, including MDR and relevant MDCGs, as well as MEDDEVs.
- Proficient in literature search and review, with a solid background in regulatory medical writing.
- Familiarity with database management systems.
- A collaborative and professional approach when engaging with stakeholders.
- Proficient in IT and skilled in using the MS Office suite.
- Fluent in both written and spoken English.
What We Offer:
- Flexible working arrangements, including adaptable hours and remote work options.
- Opportunities for international mobile working.
- Supportive measures for balancing work and family life, such as childcare subsidies.
- Generous leave policies, including 30 days of paid vacation annually, plus additional leave for significant life events.
- A comprehensive company pension plan with attractive employer contributions.
- Access to ample parking, a canteen with a café, and various employee shop offerings.
- Membership to over 6000 fitness and wellness facilities, including yoga and swimming options.
- Various health and wellness initiatives, including screenings and mental health resources.
- Job bike leasing options.
- Exclusive discounts on travel, fashion, and technology through our corporate benefits platform.
Join Us: Shape a career that prioritizes healthcare customers, is future-ready, and is rooted in a culture of trust and transparency.
