About this role
GENERAL DESCRIPTION To support the Medical Division in government tenders as a Product Specialist while managing all medical products are compliant, properly registered, and technically ready for participation in government procurement processes.
JOB DESCRIPTION
Key Responsibilities
• Support medical government tender operations (documentation preparation, submission coordination, compliance adherence) • Coordinate product onboarding, pricing, quotations, and documentation required for MedKad-related transactions. • Prepare and compile tender documents including technical specifications, forms, and supporting documentation • Ensure completeness, accuracy, and compliance of all tender submission requirements • Ensure all medical devices are registered and compliant with Medical Device Authority (MDA) requirements • Liaise with principals for product registration documents, technical files, and compliance requirements • Maintain regulatory documentation including certificates, licenses, and approvals • Track validity and renewal of regulatory documentation • Support onboarding of new medical products and ensure regulatory readiness for tender participation • Assist in product positioning and technical documentation for tender submissions • Work closely with Medical Lead and Tender Team to ensure alignment between regulatory and tender requirements • Maintain proper filing and documentation for both tender and regulatory records
Other Responsibilities:
• To participate actively in any other new service that is introduced by the organization. • Comply with Company Policies, Health and Safety Policies. • Ensure conformance to all policies and procedures of ISO 9001:2015, ISO 14001:2015, OHSAS 18001:2015, GDPMD & ISO 13485:2015. • Ensure adherence to KPJ’s Core Value at all times. • Ensure adherence to related legal requirement. • Ensure compliance with Medical Device Authority (MDA) and related regulatory requirements. • Provide processes that support healthcare stakeholders in accordance with regulatory and compliance standards.
JOB REQUIREMENT
Education: Bachelor’s Degree in Biomedical Science, Pharmacy, Regulatory Affairs, or related field. Experience or certification in Regulatory Affairs (MDA) is an added advantage.
Professional Qualification Knowledge and Experiences: Minimum 2–4 years of experience in medical devices, regulatory affairs, or healthcare-related field, with exposure to government tender processes.
Skills & Competencies: Special skills required
• Strong understanding of medical device regulations (MDA requirements) • Knowledge of product registration and regulatory documentation • Ability to manage compliance requirements • Strong documentation and coordination skills • Ability to liaise with principals and regulatory bodies
Personal attributes
• High level of integrity and accountability • Strong attention to detail and compliance mindset • Good communication and coordination skills • Ability to manage multiple tasks and deadlines • Willingness to learn and adapt to regulatory requirements