I'm supporting a fast-growing Healthtech startup driving innovation in the medical device space. You'll lead the regulatory and quality strategy across US and 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 roxyzhou@trulyyy.com

Regrettably, only shortlisted candidates will be notified.Please note that data provided is for recruitment purposes only.

Business Registration No.: 202004228R | License. No. - 20S0118 | EA Registration No. - R22104027