Job description:

With over 20 years of industry experience, ALTEN Consulting Services GmbH offers its renowned clients in industry and commerce highly specialized engineering and IT services for the joint implementation of cross-industry and cross-technology solutions.

Competence, commitment, and passion unite all our employees at ALTEN Consulting Services GmbH. A collaborative partnership, a strong sense of "we," personal contact with our clients, and the creativity of each individual are always at the forefront of our work. Become part of our success story.

Clinical Affairs Manager (all genders)

Make it happen

YOU...

- plan and coordinate PMCF and clinical evaluation activities across the entire product portfolio and ensure MDR compliance

- assess the need for additional post-market clinical data collection together with internal stakeholders

- develop strategies for generating, analyzing, and using PMCF data to ensure clinical safety, performance, and clinical benefit

- create and maintain PMCF plans and PMCF reports based on post-market surveillance data, clinical studies, and scientific literature

- support the creation of clinical evaluation documentation, incorporating preclinical, non-clinical, and clinical data

- work closely with Product Management, FE, Regulatory Affairs, and external partners, ensuring successful cross-functional coordination

Be our forward thinker

YOU...

- have a degree in medicine, natural sciences, engineering, or a comparable qualification

- bring relevant professional experience in Clinical Affairs and sound knowledge of EU-MDR and relevant MDCG guidelines

- you have practical experience in clinical evaluation, PMCF and the requirements of clinical lifecycle management

- you have a good understanding of clinical research methods, study designs, biostatistics and information management

- ideally you are familiar with magnetic resonance technology as well as regulatory frameworks in the USA and China

- you have fluent English skills, good German skills are an advantage.

A home where people learn and thrive

- Future-oriented workplace with a permanent employment contract

- Attractive salary

- Mobile working by arrangement

- Individual internal and external training opportunities

- Flexible working hours with flexitime account system

- Personal contact person

Further information can be found at: www.alten-consulting.de

We value diversity and therefore welcome all applications – regardless of gender, nationality, ethnic and social origin, religion/belief, disability, age, or sexual orientation and identity.

Applicants with disabilities will be given preference if equally qualified.

Apply now via our online application form.

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