Manage and coordinate licenses, and approvals, including liaison with external consultants and regulatory authorities (Electrical SIRIM, MCMC certifications, NPRA Notification, F&B label reviews)
Monitor regulatory developments and assess business impact, providing timely advisory to management and stakeholders.
Oversees Joint-Venture Project requiring regular communication with China Customers, providing inputs and insights and ensure progress is monitored and results are delivered.
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Working with department management provides global regulatory strategies and regulatory plans
Working with department management, communicates with US FDA, EU Notified Bodies, EU Competent Authorities and other international regulatory authorities
Coordinates/prepare and maintains FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirements
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Receive, process, assess and report adverse events, product complaints and other safety information in accordance with local and global regulatory requirements.
Ensure Individual Case Safety Reports (ICSRs) are complete, accurate and submitted within regulatory timelines.
Perform follow-up activities to obtain complete and medically relevant safety information.
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Bachelor’s degree in a relevant field such as Biomedical Engineering, Health Sciences, Pharmacy, or related discipline.
Attention to detail, strong organizational skills, and the ability to manage multiple projects and deadlines.
Effective written and verbal communication skills, with the ability to present regulatory information clearly to internal and external stakeholders.
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Manage and coordinate licenses, and approvals, including liaison with external consultants and regulatory authorities (Electrical SIRIM, MCMC certifications, NPRA Notification, F&B label reviews)
Monitor regulatory developments and assess business impact, providing timely advisory to management and stakeholders.
Oversees Joint-Venture Project requiring regular communication with China Customers, providing inputs and insights and ensure progress is monitored and results are delivered.
...
Manage and coordinate licenses, and approvals, including liaison with external consultants and regulatory authorities (Electrical SIRIM, MCMC certifications, NPRA Notification, F&B label reviews)
Monitor regulatory developments and assess business impact, providing timely advisory to management and stakeholders.
Oversees Joint-Venture Project requiring regular communication with China Customers, providing inputs and insights and ensure progress is monitored and results are delivered.
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NPRA & Regulatory Compliance: Lead and coordinate product registration, notifications, and variations with the National Pharmaceutical Regulatory Agency (NPRA / KKM). Prepare, review, and organize complete regulatory dossiers (Dossier submission, Certificate of Free Sale, ingredients validation, etc.).
Stay up to date with Malaysia food and health supplement regulations, ensuring all raw materials, formulations, and labeling meet current NPRA and KKM requirements. Serve as the main point of contact for external regulatory authorities and internal teams on regulatory matters.
Quality Assurance & Quality Control (QA/QC): Oversee daily QC testing (physical, chemical, and microbiological parameters) for raw materials, packaging materials, in-process samples, and finished products. Establish, review, and maintain QA documentation, including Standard Operating Procedures (SOPs), Certificate of Analysis (CoA), Batch Production Records (BPR), and product specifications.
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Lead and coordinate product registration, notifications, and variations with the National Pharmaceutical Regulatory Agency (NPRA / KKM).
Prepare, review, and organize complete regulatory dossiers (Dossier submission, Certificate of Free Sale, ingredients validation, etc.).
Stay up to date with Malaysia food and health supplement regulations, ensuring all raw materials, formulations, and labeling meet current NPRA and KKM requirements.
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Working with department management provides global regulatory strategies and regulatory plans
Working with department management, communicates with US FDA, EU Notified Bodies, EU Competent Authorities and other international regulatory authorities
Coordinates/prepare and maintains FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirements
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Keep abreast of University policies, procedures and developments in internal auditing, and perform other audit-related duties as assigned.
Assist the Head in implementing quality assurance activities and ensuring compliance with University policies, MQA, JPT and other regulatory requirements.
Support the preparation and submission of documentation for programme accreditation, renewal, approval, changes and other regulatory requirements, including MQA and JPT applications.
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Ensure that all raw materials comply with policies including allergen management and risk of cross contamination.
Highlight any errors/amend raw materials specifications being submitted by suppliers and make sure they are up to date with any relevant changes.
Challenge suppliers and ensure requests for information/ food safety questions are resolved/ answered promptly within the critical path timescales.
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Advise management on the legal implications of business proposals, contractual structures, commercial arrangements and project-related decisions.
Participate in project, commercial and management discussions where legal input is required, ensuring that material legal risks and contractual implications are identified sufficiently early.
Provide practical and solution-oriented legal recommendations that balance legal protection, commercial objectives, execution requirements and acceptable levels of risk.
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Conduct legal research and provide findings to support legal advisory for the Group’s business units, ensuring all contracts, policies and rules comply with applicable laws, regulations and standards.
Draft and review agreements, terms and conditions, and legal documents to meet the Group's business needs.
To participate in various types of negotiation and provide legal input as and when required.
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The customer service officer plays a pivotal role in guiding and navigating patients through the process of seeking opinions from doctors / consultants and the processes involved in getting the due treatment / medical care. Among the job descriptions include:
· Attend to patients during their visit to guide them through the processes of seeking medical opinions from consultants / doctors.
· Attend to questions and queries that the patient and/or family members may have with regards to the internal processes / flow.
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Plan and coordinate site activities based on material delivery schedules, resource requirements, site conditions, and work priorities.
Coordinate activities across different disciplines and between Contractors and the Project Management Team to resolve site issues, manage handovers, and maintain smooth project execution.
Diploma in Engineering discipline OR Degree in Engineering discipline
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Be the Subject Matter Expert in Complyadvantage (Screening Tool), and support any enhancement/process related workflows.
Handle resolution of confirmed suspicious cases, including assisting to reach out to affected customers and internal teams for further investigation.
Collaborate with Compliance and other key business functions to ensure a smooth end-to-end internal process to achieve customer satisfaction and safeguard company's and users' interests
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Coach team leads and senior analysts on case decision quality, investigative rigour and escalation judgment. Build a bench of leaders within the team, not just individual contributors.
Set individual and team performance goals, conduct regular performance reviews, and manage underperformance directly and fairly.
Define and own the KPI framework for the function, covering case turnaround times, alert to resolution SLAs, QA pass rates, STR/SAR filing timeliness and backlog ageing. Review these regularly with the team, not only at leadership reporting time
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Review and escalate suspicious transactions and ensure Suspicious Transaction Reports (STRs) and other required regulatory reports are submitted accurately and within the required timeframe.
Monitor regulatory developments and ensure the company promptly implements new or revised regulatory requirements.
Conduct and maintain assessments of money laundering, terrorist financing, proliferation financing, sanctions, fraud, and operational compliance risks.
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