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Clinical Assessment Manager
vor 2 Monaten
Join PAUL HARTMANN AG and contribute to our mission of enhancing healthcare. We are dedicated to supporting healthcare professionals, allowing them to focus on what truly matters: improving lives. With your dedication, you can advance in your career every day.
Position Overview:
As a Clinical Evaluation Manager, you will be part of a global team, engaging in a dynamic and rewarding role within an international setting. This position allows you to refine your expertise while actively participating in the execution of procedures that demonstrate compliance of medical devices with essential 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 R&D to ensure all necessary documentation is current.
- Coordinate with external service providers to assist in clinical evaluation documentation, PMCF, and PMS.
- Establish clinical evidence requirements in accordance with MDR and relevant MDCGs.
- Identify equivalence to existing devices as 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.
- 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 related regulatory environment.
- Familiarity with regulatory requirements, MDR, and relevant MDCGs, as well as MEDDEVs.
- Proficient in literature search and review, with knowledge of regulatory medical writing.
- Understanding of database management.
- A collaborative and professional approach when engaging with stakeholders.
- 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.
- International mobile working opportunities.
- Support for balancing work and family life, including childcare subsidies.
- 30 days of paid leave annually, plus additional leave for significant life events, along with vacation pay and special annual payments.
- A company pension plan with attractive employer contributions, including a matching model for deferred compensation.
- Ample parking, an on-site canteen with a café bar, and various employee shop offers.
- Access to over 6000 fitness and wellness facilities, including swimming pools and specialized fitness classes.
- A range of health and wellness initiatives, such as skin cancer screenings and mental health online courses.
- Job bike leasing options.
- Exclusive discounts on travel, fashion, and technology through our corporate benefits platform.
Shape a career focused on healthcare, designed for the future, and rooted in a culture of trust and openness.
