Regulatory Product Compliance Manager
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.
Oversees Joint-Venture Project requiring regular communication with China Customers, providing inputs and insights and ensure 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, Purchasers, Quality, 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 – Proficient
Bahasa Malaysia – Fluent
Mandarin – Fluent
Preferred Expertise (Highly Advantageous):
SIRIM Electrical & Safety Certification
MCMC Wireless / Communication Device Compliance
Food & Beverage Regulations
Cosmetics Regulations (NPRA)
Medical Devices Regulatory Compliance & GDPMD Certification