Regulatory and Quality Affairs Lead

4 weeks ago

Singapur, Singapore Trulyyy Full time

I'm supporting a fast-growing Healthtech startup driving innovation in the medical device space. You’ll lead the regulatory and quality strategy across APAC markets, ensuring compliance, accelerating product approvals, and embedding a strong culture of quality across the organization. Key Responsibilities Oversee the ISO 13485 Quality Management System to maintain compliance, effectiveness, and continuous improvement. Lead audits, inspections, and certification assessments by regulatory and notified bodies. Manage post-market surveillance and ensure timely escalation of regulatory issues. Partner cross-functionally to embed regulatory and quality considerations into product development and operations. Lead regulatory submissions for product registrations, renewals, and major amendments across US and APAC markets. Ensure the accuracy and quality of technical documentation and regulatory filings. Maintain strong relationships with global regulatory authorities to facilitate efficient approvals. Build and lead a high-performing regulatory and quality team. Promote a culture of compliance, quality, and continuous improvement. Qualifications Bachelor’s degree/Master/PHD in Life Sciences, Biomedical Engineering, or related field. Minimum 5 years’ experience in Regulatory and Quality Affairs within the medical device industry. Solid understanding of global regulations (US FDA, EU MDR, TGA, HSA) and ISO 13485. Strong project management, problem-solving, and organizational skills. Excellent communication and attention to detail. If you’re interested in this opportunity, please send your CV to Regrettably, only shortlisted candidates will be notified. Please note that data provided is for recruitment purposes only. Business registration: R | License No. 20S0118 | EA Registration No. R #J-18808-Ljbffr

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