Regulatory Affairs, Manager

23 hours ago

Bandar Sri Damansara Malaysia Biomed Global Full time 120,000 - 180,000 per year

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.RequirementsPossess 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.

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