Regulatory Affairs, Manager
Regulatory Affairs, Manager
Posted on :
16-07-2025
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1 Vacancy
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Monthly Salary
7000 - 10000
Vacancy
1 Vacancy
Posted on :
16-07-2025
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.
Employment Type
Full Time
Key Skills
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