Senior Program Officer Program Officer- Diagnostics

Project Background

Indonesias Health Security 2045 vision prioritizes strengthening national self-reliance in medical devices diagnostics and in-vitro diagnostics (IVDs) while expanding domestic manufacturing capacity. The vision further emphasizes regulatory excellence innovation and equitable access to quality diagnostics across disease areas.

PATH is supporting the Ministry of Health (MoH) Indonesia and key national stakeholders to develop a strategic roadmap for medical devices and diagnostics identify innovative technologies strengthen regulatory pathways and build an enabling ecosystem for sustainable diagnostics scale-up.

Position Summary

PATH is seeking an experienced Senior Program Officer/ Program Officer-Diagnostics to provide technical leadership and strategic guidance in strengthening Indonesias diagnostics and medical devices ecosystem. The consultant will support the development of a national strategic framework and implementation roadmap assess innovative diagnostics technologies engage with manufacturers and regulatory stakeholders and contribute to policies and recommendations that advance diagnostics access and national self-reliance.

The role requires close collaboration with government agencies regulatory bodies laboratory networks industry partners and development organizations to support Indonesias Health Security 2045 objectives.

Location - Delhi/ Jakarta

Key Responsibilities

Technical Leadership and Strategy

• Provide technical leadership across project workstreams related to diagnostics in-vitro diagnostics (IVDs) and medical devices.

• Support the development of a National Strategic Framework and Implementation Roadmap for medical devices and diagnostics in Indonesia.

• Advise on strategies to strengthen diagnostics access local manufacturing and innovation ecosystems.

• Contribute technical expertise on emerging diagnostic technologies and market trends relevant to Indonesias public health priorities.

Diagnostics and Technology Assessment

• Identify assess and curate innovative diagnostic technologies IVDs and medical devices with potential for adoption and scale-up.

• Evaluate technologies based on public health relevance feasibility scalability manufacturing potential and regulatory readiness.

• Conduct assessments of local manufacturing capabilities and opportunities for strengthening domestic production.

• Support evidence generation and prioritization of technologies aligned with national health needs.

Stakeholder Engagement and Industry Collaboration

• Engage with national and international diagnostics and medical device manufacturers industry associations and private sector partners.

• Collaborate closely with the Ministry of Health including the Directorate of Medical Devices Department of Health Laboratories and relevant technical units.

• Facilitate stakeholder consultations workshops technical working groups and expert discussions.

• Maintain effective communication and coordination between PATH and government counterparts.

Regulatory and Quality Systems Support

• Provide technical inputs on regulatory pathways standards quality management systems and market authorization processes for diagnostics and medical devices.

• Support work related to ISO 13485 compliance validation and verification processes laboratory quality systems and regulatory best practices.

• Contribute to health technology assessment (HTA)-related activities and evidence-based decision-making processes.

• Identify opportunities to strengthen regulatory and policy frameworks supporting diagnostics innovation and scale-up.

Expected Deliverables

• Documentation and technical input supporting the National Strategic Framework and Implementation Roadmap for medical devices and IVDs.

• Technical assessment report on diagnostic technologies innovation landscape and local manufacturing capabilities in Indonesia.

• Recommendations on priority diagnostics and medical devices for scale-up and ecosystem strengthening.

• Technical inputs on regulatory pathways quality systems validation frameworks and HTA considerations.

• Reports from stakeholder consultations workshops technical working groups and expert engagements.

• Policy briefs technical notes and knowledge products for government industry donor and technical audiences.

Required Qualifications

Education

• Postgraduate degree in Biomedical Engineering Biotechnology Microbiology Clinical Laboratory Sciences Public Health Health Technology or a related field.

Experience

• Minimum 56 years of professional experience in diagnostics medical devices laboratory systems health technology innovation or related fields.

• Experience supporting the development introduction evaluation or scale-up of diagnostic technologies within healthcare or public health systems.

• Experience working with medical device manufacturers diagnostics companies laboratory networks or regulatory agencies.

• Demonstrated experience supporting donor-funded government-led or multi-country health programs.

• Proven experience engaging with ministries of health development partners industry stakeholders and technical agencies.

Preferred Experience

• Familiarity with IVD product development pathways and diagnostics innovation ecosystems.

• Experience working with quality management systems and standards including ISO 13485.

• Knowledge of validation and verification processes laboratory accreditation systems and regulatory best practices.

• Experience supporting Health Technology Assessment (HTA) processes and evidence-based policy development.

• Prior experience working in Indonesia or Southeast Asia.

• Familiarity with Indonesian health sector institutions including MoH BPOM BSN provincial health offices national public laboratories and related stakeholders.

Skills and Competencies

• Strong technical expertise in diagnostics IVDs and medical devices.

• Knowledge of regulatory systems quality standards HTA methodologies and laboratory strengthening approaches.

• Excellent stakeholder engagement and facilitation skills. Strong analytical report-writing and presentation capabilities.