Clinical Affairs Manager (m/w/x)
Your role
Participate in complex project product development with R&D and PM, identify potential clinically relevant issues emerging from (absence of) features and their clinical consequences, define and implement the appropriate clinical evaluation strategy and necessary clinical studies for the product
Responsibility for budget and time planning for the entire clinical strategy and for compliance with this, taking into account economic aspects and project risks as well as defining minimization measures
Independently plan, generate and maintain clinical documentation for regulatory purposes (e.g. Clinical Evaluation Plan and Report, clinical content for regulatory submissions), including continuous gap analysis and conclusion on sufficiency of clinical evidence, adapt clinical strategy when necessary
Planning and execution of CA tasks of post-market surveillance incl. database analysis and literature search, regular update of clinical assessments
If necessary, selection and coordination of external service providers for the aforementioned activities Create and / or review manuscript for scientific publications Review and approval of product specific marketing materials and publications.
Support clinical / regulatory affairs teams worldwide in product registrations Report on project progress,
Act as an internal consultant / subject-matter expert adaptation and improvement of Clinical Affairs processes.
Your profile
Education : 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 14155)
In-depth knowledge of relevant regulatory requirements in clinical evaluations for medical devices (MDR, MPDG, MDCG, MEDDEV, IMDRF guidelines) Other knowledge
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
Your ZEISS Recruiting Team :
Celine Karbach
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