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Manager of Clinical Affairs

vor 2 Monaten


Munich, Bayern, Deutschland ZEISS Group Vollzeit

Your Role

  • Engage in intricate product development projects alongside R&D and project management teams, identifying potential clinically significant issues arising from feature deficiencies and their clinical implications. Formulate and execute the necessary clinical evaluation strategies and clinical studies for the product.
  • Oversee budget and timeline planning for the comprehensive clinical strategy, ensuring adherence to economic considerations and project risks while establishing mitigation measures.
  • Independently design, produce, and sustain clinical documentation for regulatory compliance (e.g., Clinical Evaluation Plan and Report, clinical content for regulatory submissions), including ongoing gap analysis and assessments of clinical evidence sufficiency, modifying clinical strategies as required.
  • Plan and implement clinical affairs tasks related to post-market surveillance, including database analysis and literature reviews, and provide regular updates on clinical assessments.
  • When necessary, select and coordinate external service providers for the aforementioned activities, create and/or review manuscripts for scientific publications, and review and approve product-specific marketing materials and publications.
  • Support global clinical and regulatory affairs teams in product registrations and report on project advancements.
  • Act as an internal consultant and subject-matter expert, focusing on the adaptation and enhancement of Clinical Affairs processes.

Your Profile

  • Education: A minimum of a four-year degree in optometry, medicine, medical technology/engineering, or natural sciences.
  • At least 5 years of experience in Clinical Affairs or Clinical Evaluation within the medical device sector or with contract research organizations.
  • Strong understanding of pertinent regulatory requirements for clinical trials related to medical devices (ICH-GCP, ISO).
  • Comprehensive knowledge of relevant regulatory requirements for clinical evaluations of medical devices (MDR, MPDG, MDCG, MEDDEV, IMDRF guidelines).
  • Proficient in biostatistics, data interpretation, and critical analysis of publications.
  • Familiarity with regulatory requirements for CE, FDA, NMPA, Health Canada, etc.
  • Proven capabilities in project management and medical writing.
  • Exceptional analytical skills complemented by creativity and intuition.
  • Strong commitment, innovative drive, and excellent communication and organizational skills in an international context.
  • Fluent in both oral and written English.
  • Willingness to travel internationally.

Your ZEISS Recruiting Team:

Celine Karbach