Regulatory and Quality Affairs Lead
3 days ago
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.
Business Registration No.: 202004228R | License. No. - 20S0118 | EA Registration No. - _R22104027_
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