- Location
- Pharmaserv Alliances Sdn Bhd - Headquarters, Malaysia
- Type
- Full-time
- Experience
- 2+ years
- Source
- Workday
Description
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