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Clinical Affairs Manager
vor 2 Monaten
ZEISS Group is seeking a highly skilled Clinical Affairs Manager to join our team.
About the RoleWe are looking for a seasoned professional with expertise in clinical affairs, regulatory requirements, and project management to lead our clinical strategy and ensure compliance with regulatory standards.
Key Responsibilities- Develop and implement clinical evaluation strategies for medical devices, identifying potential issues and defining necessary clinical studies.
- Plan and manage budgets and timelines for clinical projects, ensuring compliance with regulatory requirements and economic aspects.
- Generate and maintain clinical documentation for regulatory purposes, including clinical evaluation plans and reports.
- Plan and execute post-market surveillance activities, including database analysis and literature search.
- Coordinate with external service providers as needed and review manuscript for scientific publications.
- Support clinical/regulatory affairs teams worldwide in product registrations and report on project progress.
- Act as an internal consultant/subject-matter expert to adapt and improve Clinical Affairs processes.
- Minimum four-year college degree in optometry, medicine, medical technology/engineering, or natural sciences.
- At least 5 years of experience in Clinical Affairs/Clinical evaluation in the medical device industry or with contract research organizations.
- Good knowledge of relevant regulatory requirements for clinical trials for medical devices (ICH-GCP, ISO).
- In-depth knowledge of relevant regulatory requirements in clinical evaluations for medical devices (MDR, MPDG, MDCG, MEDDEV, IMDRF guidelines).
- Good knowledge in biostatistics, data interpretation, and critical reading of publications.
- Good knowledge of regulatory requirements for CE, FDA, NMPA, Health Canada, etc.
- Demonstrated qualities in project management and medical writing.
- Strong analytical skills coupled with creativity and intuition.
- Commitment and creative drive as well as strong communication and organizational skills in an international environment.
- Very good oral and written communication in English.
- Willingness to travel worldwide.
We are an equal opportunities employer and welcome applications from diverse candidates.
Contact: Celine Karbach
