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Regulatory Affairs Manager

Regulatory Affairs Manager

Biomed GlobalKuala Lumpur, Kuala Lumpur, Malaysia
30+ days ago
Job description

Position :

Regulatory Affair Manager

Industry :

Healthcare / Medical Device

Responsibilities

  • 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.

Qualifications

  • Possess a Bachelor's Degree in Science or a related discipline, with a minimum of 7 years of relevant experience in a similar capacity.

    • Required Skills

  • 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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    Manager • Kuala Lumpur, Kuala Lumpur, Malaysia