Clinical Affairs Manager (m / w / x)

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, and adapt clinical strategy when necessary.

Planning and execution of CA tasks of post-market surveillance, including database analysis and literature search, with regular updates of clinical assessments.

If necessary, select and coordinate external service providers for the aforementioned activities. Create and/or review manuscripts for scientific publications. Review and approve product-specific marketing materials and publications.

Support clinical/regulatory affairs teams worldwide in product registrations and report on project progress.

Act as an internal consultant / subject-matter expert for the 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.