The Role
Lead regional regulatory affairs for medical devices across Southeast Asia: identify and track regulatory requirements, manage pre- and post-market registrations and licenses, ensure labeling and advertising compliance, support internal and external audits, liaise with authorities and conformity assessment bodies, drive RA process improvements and digitalization, and supervise a regulatory team.
Summary Generated by Built In
- Identify regulatory requirements and stay up to date with the evolving regulatory landscape in each marketing territory.
- Serve as the company representative and committee member in local medical device industry associations (e.g., MMDA).
- Initiate, validate, review, plan, and strategize to ensure all products remain compliant with applicable statutory and regulatory requirements.
- Communicate regulatory updates to relevant internal stakeholders to ensure alignment across departments.
- Plan and drive process improvements, including the digitalization of Regulatory Affairs (RA) workflows.
- Oversee and maintain Medical Device Establishment/Dealer Licenses with the relevant authorities.
- Supervise pre-market regulatory activities including medical device registration, change notifications, and applications for special authorizations or exemptions with government bodies.
- Manage post-market regulatory obligations, including the reporting of device-related incidents and complaints, ensuring all submissions are timely and compliant with applicable requirements.
- Ensure compliance with advertisement and labeling regulations in each marketing territory.
- Oversee and supervise compliance with other regulatory requirements from authorities such as MOH (MY), HSA (SG), NEA (SG), IMDA (MY/SG), DVS (MY/SG), and AVS (MY/SG).
- Plan and lead the implementation of internal RA audits on an annual basis.
- Support external audits conducted by regulatory agencies, principals, and suppliers by providing regulatory input to minimize the risk of non-compliance findings.
- Provide regulatory support during internal audits of subsidiaries and associated companies across Southeast Asia.
- Collaborate with Conformity Assessment Bodies on product risk assessment and regulatory implementation changes.
- Support regulatory matters related to custom import requirements and documentation.
- Assist and oversee matters involving licensed pharmacists or qualified personnel, including Poison A License and inspections by the Ministry of Health.
Requirements
- Possess a Bachelor’s Degree in Science or a related discipline, with a minimum of 7 years of relevant experience in a similar capacity.
- Proficient in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
- Demonstrated track record in team leadership, preferably with experience managing a team of five or more, with strong people management capabilities including coaching and training.
- Excellent communication and interpersonal skills, with the ability to engage with regulatory authorities, consultants, auditors, and foreign manufacturers, effectively.
- In-depth knowledge and hands-on experience in medical device registration and regulatory compliance, particularly in Malaysia, Singapore, and Indonesia.
- Solid understanding of quality management systems, specifically ISO 13485, ISO 9001, and GDPMD requirements.
- Basic biomedical knowledge with the ability to understand and interpret technical aspects of medical devices.
- Strong understanding of operational workflows, with the ability to identify inefficiencies and implement process improvements.
- Meticulous and detail-oriented, capable of working independently with minimal supervision.
- Possess strong analytical and presentation skills, with the ability to translate data into meaningful insights.
- Proactive, performance-driven, and results-oriented, with a strong sense of ethical integrity and accountability in project execution.
- Pharmacist background with a valid license will be an added advantage.
Skills Required
- Bachelor's Degree in Science or related discipline
- Minimum 7 years relevant experience in regulatory affairs or similar capacity
- Proficient in Microsoft Office applications (Outlook, Excel, Word, PowerPoint)
- Demonstrated team leadership and people management, including coaching and training
- Experience managing a team of five or more
- Excellent communication and interpersonal skills for engaging regulators, consultants, auditors, and manufacturers
- In-depth, hands-on experience in medical device registration and regulatory compliance in Malaysia, Singapore, and Indonesia
- Strong understanding of quality management systems: ISO 13485, ISO 9001, and GDPMD
- Basic biomedical knowledge to interpret technical aspects of medical devices
- Experience identifying operational inefficiencies and implementing process improvements, including digitalization of RA workflows
- Meticulous, detail-oriented, able to work independently with minimal supervision
- Strong analytical and presentation skills
- Proactive, performance-driven, ethical and accountable in project execution
- Pharmacist background with a valid license
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The Company
What We Do
Biomed Global is a leading total solution provider in the biomedical and life sciences industry, operating across Southeast Asia. The company provides a holistic range of innovative medical solutions and cutting-edge biomedical technologies spanning research, development, and clinical applications. Its mission is to advance healthcare standards and facilitate medical breakthroughs by bringing together leading-edge medical solutions and expert support to enrich lives.
