Regulatory Strategy & Compliance
~- German Federal Institute for Drugs and Medical Devices, BfArM) and EU Notified Bodies.
~- Build and lead cross-functional teams (regulatory affairs, clinical affairs, market access, sales).
~- Lead local market access strategies, including health insurance (GKV) negotiations and DRG compliance.
10+ years of experience in the EU medical device industry, including 3+ years in senior management roles.
~ In-depth knowledge of EU medical device regulations (MDR/IVDR) with proven success in Class II/III device registrations.
~- Prior experience leading international projects for Chinese enterprises is preferred.
~- Chinese language proficiency preferred (not mandatory).
~ Willingness to undertake frequent international travel (6-8 annual trips to China headquarters for coordination).