Project & Business Coordinator

Key Responsibilities :

01  Project Execution & Progress Tracking

·   Coordinate routine laboratory communication, equipment and reagent readiness, technical training and on-site arrangements for the TB-EASY clinical validation project; clinical research decisions remain with the designated experts.

·   Track project milestones, action lists, dependencies and execution risks; work with Hugo's technical team, Sigma and local institutions to implement approved plans.

02  Local Partner Communication

·   Manage routine coordination with established contacts at government agencies, laboratories, universities and local companies, including meetings, document exchange and follow-ups.

·   Monitor meeting action items and promptly report new partner requirements, obstacles and significant issues to the Business Lead.

03  Local Operations & Business Support

·   Organize project visits, training activities and necessary on-site coordination; collect and consolidate local feedback.

·   Resolve routine matters independently within the agreed scope of authority, maintain traceable records and reduce repetitive cross-border communication.

04  New Project Coordination

·   Support the preparation of wastewater surveillance and other approved new initiatives by liaising with existing local contacts, collecting information and coordinating pilot readiness.

05  Reporting & Document Management

·   Provide weekly updates covering progress, upcoming actions, open issues and project trackers; maintain contact lists, minutes and project files.

·   Promptly report material issues through the agreed reporting line and ensure accuracy, confidentiality and traceability of information.

06  Regulatory Affairs (RA) Documentation Review

·   Review Indonesia-bound medical device/IVD registration documents already prepared by Hugo for validity, product/model consistency, labels, instructions for use, authorization letters, certificates and technical-document checklists.

·   Check local compliance against applicable Kemenkes and e-Regalkes requirements, issue written gap/consistency lists, and coordinate corrective actions with Hugo's RA team and Sigma's designated registration representative.

·   The role covers local regulatory alignment and dossier review only; it does not include primary drafting of core technical materials, formal application submission or guarantees of regulatory approval.

Qualifications :

·   Bachelor's degree or above; preference for Clinical Medicine, Medical Laboratory Science, Biomedical Sciences, Biotechnology, Pharmacy, Public Health, Biomedical Engineering or related medical/life-science disciplines.

·   1–3 years of relevant experience in Indonesian healthcare project coordination, medical device/IVD regulatory affairs or registration documentation review.

·   Required: practical familiarity with Kemenkes medical device/IVD regulatory processes, e-Regalkes dossier requirements, deficiency responses and local document-compliance checks.

·   Fluent Bahasa Indonesia and good written and spoken English; proficient in Microsoft Word, Excel and PowerPoint.

·   Strong follow-through, coordination and issue-reporting skills; available for necessary local meetings and site visits in Jakarta.