Key Responsibilities:
Regulatory Compliance & Product Governance:
- Establish, maintain, and continuously update regulatory and technical compliance requirements across multiple product categories, including Household Products, Electrical Appliances, Medical Devices, Cosmetics, Wireless Devices, Toys, Food & Beverage, and Packaging & Labelling.
- Lead regulatory assessments and approval processes for new product onboarding and existing product maintenance.
- Oversee and maintain GDPMD certification, ensuring continuous audit readiness and compliance with Medical Device Authority (MDA) requirements.
- 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.
- Oversee Joint-Venture Projects requiring regular communication with China Customers, providing inputs and insights, ensuring progress is monitored and results are delivered.
Documentation, Certification & Regulatory Filing:
- Ensure accurate preparation, review, endorsement, and submission of compliance documentation, certificates, permits, and licenses.
- Maintain a centralized compliance tracking system for product approvals, renewals, and regulatory validity.
- Ensure proper record-keeping and documentation integrity to support audits, inspections, and internal governance.
- Oversee regulatory submissions and correspondence with authorities where required.
Stakeholder Management & Operational Support:
- Partner closely with Trade, Purchasing, Quality, and Supply Chain teams to resolve compliance issues.
- Represent Product Compliance in internal project discussions, highlighting regulatory risks, mitigation plans, and required actions.
- Track, analyze, and report compliance KPIs to drive continuous improvement and risk management.
- Support and guide junior team members in regulatory interpretation and compliance execution.
- Perform additional duties as assigned by management in line with business needs.
Requirements
- :Bachelor's Degree in Biomedical Sciences, Biomedical Engineering, Life Sciences, Engineering, or a related discipline
- .Minimum 5 years of experience in product compliance, regulatory affairs, or related roles (experience in retail, FMCG, or multi-category environments is an advantage)
- .Strong working knowledge of Malaysia's regulatory framework across multiple product categories
- .Strong leadership, stakeholder management, and problem-solving skills with high attention to detail
- .Coach and manage team members to deliver high morale and performance to drive company growth
- .Experience managing regulatory audits, inspections, and authority engagements
- .Familiarity with ISO, quality management systems, and compliance-driven environments
- .Ability to work independently and manage multiple priorities in a fast-paced environment
.Language Proficiency
- :English Proficien
- tBahasa Malaysia Fluen
- tMandarin Advantageou
sPreferred Expertise (Highly Advantageous)
- :SIRIM Electrical & Safety Certificatio
- nMCMC Wireless / Communication Device Complianc
- eFood & Beverage Regulation
- sCosmetics Regulations (NPRA
- )Medical Devices Regulatory Compliance & GDPMD Certificatio
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