Regulatory Compliance Manager

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 – Advantageous)

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