Regulatory Affairs

3 days ago


WorkFromHome, Hong Kong SAR China Michael Page International (Hong Kong) Limited Full time

Innovate in next-gen surgical robotics Join a fast-growing medtech pioneer About Our Client Our client is a fast-growing, Hong Kong-based technology company specializing in precision robotics. With a strong focus on innovation, they develop advanced hardware solutions for medical and industrial applications. The team is made up of top-tier engineers and researchers, and the company offers a dynamic, collaborative environment where cutting-edge ideas are turned into impactful products. Job Description Oversee quality systems and regulatory compliance across sites Maintain certifications (ISO 13485, CE, FDA 510(k), NMPA) Lead audits, internal training, and documentation Manage supplier quality and customer-related issues Support regulatory submissions and product validations Report quality performance to senior management Guide and mentor QA team members The Successful Applicant Degree in science, engineering, or related field 8+ years of experience, with 3+ in QA management (medical device preferred) Strong knowledge of ISO 13485, FDA, CE, NMPA Excellent leadership, communication, and problem-solving skills Fluent in English, Cantonese, and Mandarin Willing to travel as needed What's on Offer 5-day work 14day Annual Leave Performance Bonus Medical Insurance (Family memebers covered) Work from Home #J-18808-Ljbffr



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