Toxicology and Biosafety
Senior Consultant Biosafety
MSc, PhD KU
Available for: Part-time, full-time
Contact us for full CV
- Biosafety and Clinical evaluation (WMDO certificate).
- Risk analysis (Codex Alimentarius, OIE standards).
- Safety assessment (ISO 10993 standards).
- Multi-disciplinary project management.
- Strategic planning and execution of activities supporting industry board goals.
- Post-Market Clinical Follow-up (PMCF) plans and reports.
- National and international grant applications.
- Clinical Evaluation Reports on medical devices (face masks, resuscitators) as part of MDR transition.
- Biological Evaluation Report on a suction/irrigation device for laparoscopic surgery.
- Biological Evaluation Reports on CBD based products for treatment of psoriasis and arthritis.
- Clinical and technical reviews to Notified Bodies regarding MDR transferred medical devices like resuscitators and laryngeal masks.
- External examiner at Copenhagen University.
- Experience with Balanced Score Card and quality assurance including third party audits.
Extensive knowledge in:
- Clinical evaluation according to MDR regulations and MEDDEV 2.7.1 rev. 4: author and evaluator of Clinical Evaluation Reports, Clinical Evaluation Plans, and Post-Market Clinical Follow-up reports (WMDO certified).
- Trained in Clinical procedures, Design control, Risk management according to corporate quality management.
- ISO 10993 for biosafety of medical devices including toxicological safety assessments and Biological Evaluation Reports.
- Risk assessments for food safety and animal health carried out according to OIE and Codex Alimentarius standards.
Is empathic, open-minded and a natural communicator who thrives on working with diverse groups of people. Prefers a systematic approach in his work, keeping the overview from start to finish. He values respect, trust, credibility and loyalty in his collaborations. In his free time he enjoys running, hiking, gardening, books, music, and his aquarium. He is fluent in Dutch (mother tongue), English and Danish.
Arne Jacobsens Alle 15-17
DK-2300 København S
(+45) 48 24 51 13
Where to find us