As our first dedicated Regulatory Affair Associate, you will play a pivotal hands-on role in building and executing our global regulatory strategy.

Responsibilities:

· Manage device classification, predicate selection, substantial equivalence argument, and labeling requirements.

· Support clinical and performance evaluation strategy, including liaison with CROs and clinical investigators.

· Prepare, compile, and submit regulatory dossiers

· Lead the creation and maintenance of Technical Files, Design Dossiers, Risk Management Files, Clinical Evaluation Reports, and Post-Market Surveillance plans

· Collaborate closely with R&D, Quality, and Clinical teams to ensure design control and risk management inputs are regulatory-compliant from the start.

Requirements:

· Bachelor's degree in Life Science, Biotechnology, Engineering, or related disciplines.

· Experience with regulator frameworks (FDA, NMPA, MDR, …) and documentation will be a big plus

· Excellent organizational, communication, and coordination skills.

· Manage multiple priorities in a deadline-driven environment without micromanagement

· Team player with great interpersonal skills and a strong sense of ownership