Company Profile

IASON consulting GmbH & Co. KG is a specialized consulting company in the field of medical devices and pharmaceuticals. Since 2004, we have supported our clients in all regulatory and clinical matters – from planning and the preparation of scientific documentation through to submission to notified bodies and regulatory authorities.

For approximately four years, IASON consulting has also been developing software solutions to accelerate the approval and post-market surveillance of medical devices in the EU market.

Since its establishment in 2004, we have been assisting companies in more than 20 countries in the development and approval of life science products.

Job Description

To strengthen our team, we are looking for a Scientific Associate (m/f/d) in the field of Medical Writing for Clinical Affairs – Medical Devices.

Your Responsibilities

• Preparing, revising and maintaining Clinical Evaluation Reports (CERs) in accordance with the MDR and relevant guidelines (MEDDEV 2.7/1 Rev. 4, MDCG) in English.

• Drafting other scientifically sound documents for Clinical Affairs, such as Literature Reviews, Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) documentation.

• Conducting research and critically evaluating scientific and clinical publications, as well as clinically relevant data.

• Ensuring consistency, traceability and regulatory compliance across all prepared documents.

• Candidates with significant relevant professional experience may also take on consulting assignments as well as project support and project management responsibilities.

Your Profile

• A completed university degree in medicine, life sciences, pharmacy or a comparable field.

• Experience in Medical Writing, ideally with a focus on clinical documentation for medical devices.

• Knowledge of relevant regulatory frameworks (MDR, MEDDEV, MDCG Guidance).

• Strong analytical skills and excellent scientific writing abilities.

• Excellent written and spoken German and English skills (C1 level or higher).

• Strong communication skills, the ability to work independently, a high level of teamwork, a quick grasp of new concepts, willingness to learn and attention to detail.

The key qualities we value most are the motivation and ability to continuously develop professionally, a constructive and professional approach to feedback, and the ability to work independently and with precision.

What We Offer

• The opportunity to work for a specialized and growing consulting firm with a high level of professional expertise.

• Exciting projects with leading companies in the medical technology industry.

• On-the-job training with dedicated one-to-one mentoring, as well as continuous professional development and training opportunities.

• Bright, modern offices with ergonomically adjustable workstations.

• Flat hierarchies, short decision-making processes and a collaborative company culture in which new ideas can be implemented quickly.

• Flexible working hours (flexitime).

• Excellent accessibility from the Aachen and Cologne/Bonn metropolitan areas via the motorway.

• Individual career development opportunities.

• A competitive compensation package based on qualifications and professional experience.

Contact

Interested? Please send your complete application documents (cover letter in English, CV and relevant certificates) to m.woitok@iasonconsulting.com.