My client is a leading surgical robot company in China, which is expanding their business in Europe.
Responsibilities
* Regulatory Strategy & Compliance
* - Establish long-term partnerships with regulatory authorities (e.g., German Federal Institute for Drugs and Medical Devices, BfArM) and EU Notified Bodies.
* - Ensure alignment with EU MDR/IVDR regulations and CE certification requirements.
* Localized Operations Setup
* - Build and lead cross-functional teams (regulatory affairs, clinical affairs, market access, sales).
* - Develop a 3-year strategic roadmap for Germany and pan-European market expansion.
* China-Europe Resource Integration
* - Establish a European clinical evaluation center and Key Opinion Leader (KOL) network.
* - Collaborate with China R&D teams to adapt products for EU market requirements.
* Market Expansion
* - Develop distribution networks in the DACH region (Germany, Austria, Switzerland), focusing on hospital and clinic channels.
* - Lead local market access strategies, including health insurance (GKV) negotiations and DRG compliance.
Qualifications
* Professional Background
* - Master’s degree or higher (preferred fields: Biomedical Engineering, Clinical Medicine, or MBA with relevant industry focus).
* - 10+ years of experience in the EU medical device industry, including 3+ years in senior management roles.
* Core Competencies
* - In-depth knowledge of EU medical device regulations (MDR/IVDR) with proven success in Class II/III device registrations.
* - Experience in building multinational teams from scratch and managing matrix organizations.
* - Familiarity with DACH healthcare procurement systems (e.g., GPO/IDN models).
* Cultural Alignment
* - Prior experience leading international projects for Chinese enterprises is preferred.
* - Chinese language proficiency preferred (not mandatory).
* Additional Requirements
* - Willingness to undertake frequent international travel (6-8 annual trips to China headquarters for coordination).