Regulatory Affairs Manager at Inventas AS, is an experienced international regulatory affairs manager with 20 years’ experience from regulatory affairs, quality management and business development in the fields of medical devices and pharmaceuticals. His qualifications include M.Sc. (Ecology) and B.Sc. (Biology) from NTNU, Trondheim.
He has extensive experience with regulatory requirements, post-market vigilance and quality and risk management as per ICH and ISO, technical transfers and GMP production. Among other things, he has worked with the development of technical documentation and quality management system for medical devices in accordance with ISO13485 and MDD (93/42 EEC) and MDR (2017/745). He also brings broad experience in business development and market access including health economic analysis and price and reimbursement positioning as well as development of international supply chain and distribution solutions.