Regulatory Affairs, Manager

Job Description

• 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.

#J-18808-Ljbffr