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 preclinical team, we are seeking a scientific associate (m/f/d) with professional experience in regulatory toxicology, biosafety, or the preclinical evaluation of medical devices, pharmaceuticals, or similar regulated products.

• Research, analysis, and critical evaluation of toxicological, biological, and scientific data from technical literature, databases, test reports, and manufacturer documentation

• Preparation of scientific and regulatory assessments in the field of toxicology and biological safety for medical devices and pharmaceuticals

• Derivation of health-based limit values (e.g., PDE, ADE, TTC, and comparable toxicological reference values) as well as evaluation of substances, materials, manufacturing processes, chemical characterization data, impurities, and extraction and leachables data within the framework of biological safety assessments

• Advising our clients on issues related to biological safety, toxicology, and regulatory strategy within the context of national and international approval procedures

• As you gain experience, you will take on independent responsibility for providing scientific advice to our clients and for the technical management of projects

Qualification Profile

• A master’s degree in toxicology, pharmacy, human medicine, chemistry, or a comparable scientific field; a Ph.D. is preferred

• At least 3 years of relevant professional experience in the field of toxicology, biosafety, risk assessment, or regulatory evaluation of medical devices, pharmaceuticals, or related health products is strongly preferred

• Experience in preparing toxicological assessments, Biological Evaluation Reports, or comparable scientific-regulatory documentation is an advantage

• In-depth knowledge of human toxicology as well as relevant regulatory requirements and standards, particularly the MDR and ISO 10993

• Experience in critically evaluating scientific literature and deriving toxicological conclusions and risk assessments

• Strong analytical skills and scientific writing proficiency

• Very good written and spoken German and English (C1 level or higher)

• Strong communication skills, ability to work independently, strong team orientation, quick comprehension, willingness to learn and attention to detail

Location

All activities are carried out together with the team at the Niederzier site with flexible working hours.

We Offer

• Join a specialized, growing consulting company with a high level of technical expertise

• Exciting projects with leading companies in the medical technology and pharmaceutical industries

• Ongoing training and professional development opportunities

• Bright, modern offices with ergonomically adjustable workstations

• Flat hierarchies, quick decision-making processes, and a collaborative corporate culture where new ideas can be implemented quickly

• Flexible work hours (flexible schedule)

• Very easy access from the Aachen and Cologne/Bonn metropolitan areas via the highway

• Individual development opportunities

• Performance-based compensation package based on professional qualifications and relevant work experience

Contact

Interested? Then please send your complete application documents (cover letter in English, CV, certificates, salary expectations) to: 

Dr. Mira Woitok (m.woitok@iasonconsulting.com)