Job description:

As a multi-award-winning top employer, we have stood for individual and appreciative support and long-term career prospects for over 40 years. We personally guide you on your career path and create a work environment that makes you #completelyjobhappy.

For our client, an internationally operating technology group, we are seeking a Clinical Affairs Specialist (m/f/d) PMCF & EU-MDR for their Erlangen location on a temporary basis, starting as soon as possible.

Benefits

- Personal support throughout the entire assignment

- Part-time position with 21 hours per week in an international Siemens Healthineers environment

- Challenging interface role between Clinical Affairs, Regulatory Affairs, R&D, and Product Management

- Work on clinical evaluation activities, PMCF documentation, and medical device regulations

Tasks

- Planning and coordination of PMCF and clinical evaluation activities across the product portfolio

- Creation and maintenance of PMCF plans and PMCF reports together with relevant stakeholders

- Evaluation of clinical data from post-market surveillance, clinical trials, and scientific literature

- Support of clinical evaluation documentation with a focus on preclinical, non-clinical, and clinical data

- Coordination with Product Management, Research & Development, Regulatory Affairs, and external partners such as Medical Writing

Profile

- Completed degree in medicine, natural sciences, engineering, medical technology, life sciences, or a comparable field

- At least 3 years of experience in Clinical Affairs, Clinical Lifecycle Management, clinical evaluation, PMCF, or medical device regulations

- Very good knowledge of EU-MDR, MDCG guidelines and regulatory requirements for clinical activities

- Experience in designing processes for clinical lifecycle management and clinical evaluations

- Fluent English skills as well as strong presentation and communication skills; German language skills are an advantage.

Unsure if the position is right for you? Apply anyway - together we'll find out how your strengths fit into our #RundumITEngineering team.

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