The Role
Track regional regulatory landscapes and independently manage pre-market registrations, change notifications, special authorizations, and post-market reporting. Ensure advertising and labeling compliance, maintain authority-specific submissions, perform internal RA audits, support external and supplier audits, update ERP and regulatory databases, and contribute to regulatory projects and process improvements across Southeast Asia.
Summary Generated by Built In
- Stay up-to date with the Regulatory landscape in each Marketing Territory.
- Independently and consistently ensure products compliance with applicable statutory and regulatory requirements by assessing, planning and executing Pre-market registration, Change notification, Special Authorization / Exemption Applications.
- Independently execute Post Market reporting timely and fulfill necessary requirements as part of post-market surveillance in documents and records keeping .
- Able to maintain compliance to advertisement regulations and respective labeling requirements in each marketing territory.
- Independently execute Other Authorities Compliances with relevant authorities / government bodies such as Poisons (MOH MY, HSA SG), Flammables & Hazardous Substance (HS) (NEA SG); SIRIM/ IMDA (MY; SG); DVS/ AVS (MY; SG).
- Independently execute yearly RA Audits internally and document findings effectively.
- Support external regulatory agency audits/ Principal audits/ Supplier audits, providing regulatory input to minimize potential for findings of non-compliance.
- Support internal audits of respective subsidiaries and associated companies in South East Asia on Regulatory matters.
- Support Routine Product Compliance Status (MDA, HSA, Other Authorities) Updates into ERP Systems, Verifying Product Compliances, updating product master list, IT batch uploads and logistic uploads for MDA Labeling database.
- Support Routine Updating of Registration master list (Regulatory Database).
- Actively participate in regulatory projects and provide inputs to process improvement.
Requirements
- Proactive, high performance, result oriented and manage
projects with ethical integrity.
- Excellent written and Verbal communication skills with the
ability to listen, articulate and advocate.
- Possess good communication skills and ability to liaise with
authorities, consultants, auditors and foreign manufacturers.
- Scientific knowledge must be able to digest complex data
while keeping the big picture through good analytical skills.
- Technical system skills (e.g. MS office applications,
databases, efficient online research).
- Good organizational skills, meticulous, planning and
presentation skills.
- Demonstrate both creative and critical thinking skills.
- Good in understanding processes/workflows, keen to innovate
and improve.
Skills Required
- Experience executing pre-market registrations, change notifications, and special authorization/exemption applications
- Experience managing post-market reporting and post-market surveillance documentation
- Knowledge of regional regulatory authorities (e.g., MOH MY, HSA SG, MDA, NEA, SIRIM, IMDA, DVS/AVS)
- Ability to maintain advertising and labeling compliance across marketing territories
- Ability to plan and execute internal regulatory audits and support external audits
- Experience working with ERP systems and regulatory/databases, including batch uploads and product master updates
- Strong written and verbal communication skills; ability to liaise with authorities, consultants, auditors, and manufacturers
- Scientific knowledge and analytical skills to interpret complex data
- Proactive, results-oriented, high integrity with project management capability
- Technical system skills (MS Office, databases, efficient online research)
- Good organization, meticulousness, planning and presentation skills
- Creative and critical thinking; process/workflow understanding and improvement mindset
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The Company
What We Do
Biomed Global is a leading total solution provider in the biomedical and life sciences industry, operating across Southeast Asia. The company provides a holistic range of innovative medical solutions and cutting-edge biomedical technologies spanning research, development, and clinical applications. Its mission is to advance healthcare standards and facilitate medical breakthroughs by bringing together leading-edge medical solutions and expert support to enrich lives.
