Project Leader Product Development - France
- As a Project Leader Product Development, you will help transfer company products from research use only (RUO) to in vitro-diagnostics (IVD) status, to guarantee our products can safely be used to diagnose patients.
- Our company offers a young and dynamic working environment with good connections to labs worldwide and an opportunity to contribute to products that make a difference in a patient’s life.
- Creating in-depth knowledge on the clinical background of individual products for determining and evaluating their intended use, diagnostic/clinical validity, etc. This can be achieved by performing literature reviews, attending conferences, contacting external experts, etc.
- Reviewing and evaluating the product’s design, and improve if necessary.
- Creating and evaluating various design control deliverables, such as product risk analyses, design and development plans, and literature study reports.
- Moderating and chairing design review meetings.
- Writing, editing and maintaining technical documentation in line with relevant regulatory requirements.
- Maintaining clear and effective communication with other departments within the company and processing their input.
- Contributing to company-related processes, such as quality assurance.
- PhD degree in Biology or Biomedical Sciences is preferred (starter).
- Adequate knowledge on genetics.
- Affinity with procedures and systems.
- Well-developed analytical skills.
- Precise, detailed and flexible.
- Ability to meet deadlines.
- Able to work alone as well as part of a team.
- Advanced writing and communication skills in English.