AVP / VP of Regulatory and Quality Affairs

ResponsibilitiesStrategic Leadership & Planning Develop and execute the APAC regulatory and quality affairs strategy aligned with businessobjectives and market expansion goals. Define and drive the regulatory pathway strategy for product portfolios to optimize time-tomarketand competitive positioning. Support data privacy and information security initiatives in partnership with the InformationSecurity teams to fulfill national data privacy and Information Security regulatory requirements.Quality Management System Oversight Provide oversight of the Quality Management System (ISO 13485) to ensure effectiveness,compliance, and continuous improvement. Lead preparation and responses for regulatory inspections, audits by Notified Bodies, andcertification body assessments. Oversee post-market surveillance programs and ensure timely escalation and resolution ofregulatory issues. Partner with cross-functional teams to integrate regulatory and quality considerations intoproduct development, business planning, and commercial strategies.Regulatory Submissions & Approvals Lead and directly manage critical regulatory submissions for pre-market product registrations,license renewals, and major amendments across US and APAC markets. Oversee the preparation and quality of technical documentation, dossiers, and regulatoryfilings to ensure accuracy and compliance. Develop and maintain relationships with regulatory authorities to facilitate efficient reviewprocesses and address regulatory questions.Team Leadership & Development Build, lead, and mentor a high-performing regulatory and quality affairs team. Develop organizational capabilities and foster a culture of quality, compliance, and continuousimprovement.Qualifications And Competency At least Bachelor’s degree in Life Sciences, Biomedical Engineering or a related field. At least 5 years of professional experience in regulatory affairs and quality affairs in medicaldevice industry. In-depth knowledge of global regulatory frameworks (US FDA, EU MDR, TGA, SG HSA etc) Strong knowledge and understanding of ISO 13485, manufacturing and quality standards Excellent project management, organizational and problem solving skills Strong attention to details with the ability to manage multiple priorities and deadlines. Excellent written and verbal communication skills Background in software development or medical device manufacturing would be an addedadvantage.