AVP / VP of Regulatory and Quality Affairs
4 days ago
Responsibilities Strategic Leadership & Planning (a) Develop and execute the APAC regulatory and quality affairs strategy aligned with business objectives and market expansion goals. (b) Define and drive the regulatory pathway strategy for product portfolios to optimize time‐to‐market and competitive positioning. (c) Support data privacy and information security initiatives in partnership with the Information Security teams to fulfill national data privacy and Information Security regulatory requirements. Quality Management System Oversight (a) Provide oversight of the Quality Management System (ISO 13485) to ensure effectiveness, compliance, and continuous improvement. (b) Lead preparation and responses for regulatory inspections, audits by Notified Bodies, and certification body assessments. (c) Oversee post‐market surveillance programs and ensure timely escalation and resolution of regulatory issues. (d) Partner with cross‐functional teams to integrate regulatory and quality considerations into product development, business planning, and commercial strategies. Regulatory Submissions & Approvals (a) Lead and directly manage critical regulatory submissions for pre‐market product registrations, license renewals, and major amendments across US and APAC markets. (b) Oversee the preparation and quality of technical documentation, dossiers, and regulatory filings to ensure accuracy and compliance. (c) Develop and maintain relationships with regulatory authorities to facilitate efficient review processes and address regulatory questions. Team Leadership & Development (a) Build, lead, and mentor a high‐performing regulatory and quality affairs team. (b) Develop organizational capabilities and foster a culture of quality, compliance, and continuous improvement. Qualifications and Competency (a) At least Bachelor's degree in Life Sciences, Biomedical Engineering or a related field. (b) At least 5 years of professional experience in regulatory affairs and quality affairs in medical device industry. (c) In‐depth knowledge of global regulatory frameworks (US FDA, EU MDR, TGA, SG HSA etc). (d) Strong knowledge and understanding of ISO 13485, manufacturing and quality standards. (e) Excellent project management, organizational and problem‐solving skills. (f) Strong attention to details with the ability to manage multiple priorities and deadlines. (g) Excellent written and verbal communication skills. (h) Background in software development or medical device manufacturing would be an added advantage. #J-18808-Ljbffr
-
AVP / VP of Regulatory and Quality Affairs
4 days ago
Singapore RESPIREE PTE. LTD. Full timeResponsibilities Strategic Leadership & Planning (a) Develop and execute the APAC regulatory and quality affairs strategy aligned with business objectives and market expansion goals. (b) Define and drive the regulatory pathway strategy for product portfolios to optimize time‑to‑market and competitive positioning. (c) Support data privacy and information...
-
AVP / VP of Regulatory and Quality Affairs
6 days ago
Singapore RESPIREE PTE. LTD. Full timeRoles & Responsibilities Responsibilities: Strategic Leadership & Planning (a) Develop and execute the APAC regulatory and quality affairs strategy aligned with business objectives and market expansion goals. (b) Define and drive the regulatory pathway strategy for product portfolios to optimize time-tomarket and competitive positioning. (c) Support data...
-
Analyst/AVP, Regulatory Affairs Team
2 weeks ago
Singapore MUFG Bank, Ltd Full timeAnalyst/AVP, Regulatory Affairs Team page is loaded## Analyst/AVP, Regulatory Affairs Teamlocations: Singapore Office Marina Onetime type: Full timeposted on: Posted 16 Days Agojob requisition id: -WDDiscover your opportunity with Mitsubishi UFJ Financial Group (MUFG), one of the world's leading financial groups. Across the globe, we're 150,000 colleagues,...
-
Regulatory Reporting Avp/vp
5 days ago
Singapore Ethos BeathChapman Full time**Job Details**: **Location** Singapore **Salary** Competitive Salary **Job Type** Permanent **Ref** BH-172015 **Contact** Shalynn Ler **Contact phone** 65 6692 0745 **Posted** 44 minutes ago - Stable Regional Bank - Excellent exposure to reporting requirements - Senior stakeholder management A renowned regional bank is looking for a Regulatory...
-
Singapore Bank of America Full timeAVP/VP, Project Manager, APAC NFRR Transformation, Global Operations Join to apply for the AVP/VP, Project Manager, APAC NFRR Transformation, Global Operations role at
-
Quality and Regulatory Affairs Specialist
6 days ago
Singapore MAJETON PTE. LTD. Full timeRoles & Responsibilities At Majeton, we are driven by our commitment to deliver “The Right Product for Health”. Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products. We are seeking a meticulous and experienced Quality...
-
Analyst/avp, Regulatory Affairs Team
5 days ago
Singapore MUFG Bank, Ltd., Singapore Office Full time**Do you want your voice heard and your actions to count?** Discover your opportunity with Mitsubishi UFJ Financial Group (MUFG), one of the world’s leading financial groups. Across the globe, we’re 150,000 colleagues, striving to make a difference for every client, organization, and community we serve. We stand for our values, building long-term...
-
Regulatory and Quality Affairs Lead
3 days ago
Singapore TRULYYY PTE. LTD. Full timeI'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...
-
Singapore Blackstone Full timeLegal & Compliance – Singapore Compliance, AVP/VP Join to apply for the Legal & Compliance – Singapore Compliance, AVP/VP role at Blackstone . Blackstone is the world's largest alternative asset manager. We seek to create positive economic impact and long-term value for our investors, the companies we invest in, and the communities in which we work. We...
-
Singapore Blackstone Full timeLegal & Compliance – Singapore Compliance, AVP/VP Join to apply for the Legal & Compliance – Singapore Compliance, AVP/VP role at Blackstone . Blackstone is the world’s largest alternative asset manager. We seek to create positive economic impact and long-term value for our investors, the companies we invest in, and the communities in which we work. We...
