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).
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