Regulatory Affairs Professional (Chinese speaking)

Do you have a passion for the medical device industry and a sharp eye for global compliance? Are you ready to make a real impact on patients' vision worldwide? For our client we are looking for an ambitious Regulatory Affairs Professional. In this role, you will play a key part in supporting growing activities in Asia.

You are a detail-oriented team player who thrives in an international setting. You enjoy bridging cultures and translating complex legislation into clear actions. You have at least 3 years of experience in medical device registrations and work at an HBO thinking level. Because you speak and write both Chinese (Mandarin) and English fluently, you are the perfect link to our Asian markets. You combine strong analytical skills with a quality-driven mindset and a hands-on, proactive attitude.

• 3+ years experience;
• HBO working and thinking level;
• fluently in Chinese (Mandarin) & English;
• proactive & quality-driven.

As a Regulatory Affairs Professional, you are at the heart of the global compliance strategy. You ensure that innovative products meet international requirements and remain available to patients globally. You focus specifically on registrations for the Chinese and Asian markets by preparing and updating registration dossiers. You will never work in isolation; you monitor legislative changes and provide regulatory guidance to cross-functional teams like QA, R&D, and Engineering. Finally, you identify opportunities to further improve our internal RA processes.

• China and Asia as focal points;
• registration of dossiers and documentation;
• legislative monitoring;
• cross-functional guidance;
• process improvement.

You will join a professional company with over 35 years of experience in ophthalmic innovation. It is the most sustainable company in Gelderland. You will work in a team of 185 colleagues where an informal and friendly atmosphere prevails. The company is known for its personal approach and focus on health—offering everything from fresh soup and nuts to social team outings and food trucks organized by the employee association.

Do you fully identify with this vacancy? Then apply quickly!

Randstad Apeldoorn

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