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