Very strong analytical skills and a solid scientific background as M.Sc. in chemical engineering and Ph.D. in biophysical chemistry. Broad experience with medical devices acquired through more than 20 years in many different roles in the medical device and pharma industries.
Project management: Project management of combination product / device development projects, from early stage to manufacturing and supply chain setup. Project management of remediation programs (documentation improvements) for drug/device combination products. Life cycle and change management of medical devices and combination products.
QA/RA: Solid experience with all aspects of ISO 13485, MDD, MDR, and CFR 21 part 820; in particular regarding Design Controls and manufacturing controls. Good understanding and knowledge of GMP for drugs and biologics. Experienced author of documentation for regulatory submissions.
Technical insight: Experience from 20 years in medical device R&D within in areas of injection devices, needle free delivery systems, in vivo glucose monitoring systems (sensors), and topical absorbable haemostats.
Medical Device QA Manager (External consultant) QA support for drug-device combination product development projects as well as for life cycle management projects; Release of Medical Devices for development purposes. Support for documentation strategies (‘platforming’). Support for QMS changes.