Registration Officer / Regulatory Affairs

PT Biomedikal Scientific Indonesia; Jakarta Selatan; On-site; IDR 78,120,000 - 133,920,000; Full time

Benefits offered by this job

Competitive salary

BPJS Health

BPJS Employment

Transport allowance

Travel allowance

Career development

Collaborative environment

Job summary

PT Biomedikal Scientific Indonesia in South Jakarta seeks a Registration Officer / Regulatory Affairs to manage medical device registrations and regulatory dossiers with the Ministry of Health and related authorities. The role requires a Bachelor’s in a science field, strong English, and knowledge of CDAKB Internal Audit and E‑Report/OSS systems.

You will work with Marketing and Product teams to ensure compliant registrations and timely renewals.

Qualifications

• Bachelor’s degree in Pharmacy, Biology, Chemistry or related field.
• Experience in regulatory affairs (preferred in medical devices/ALKES distribution).
• Excellent service orientation and integrity with teamwork mindset.
• Understanding of CDAKB – Internal Audit, E‑report and OSS systems.

Responsibilities

• Register medical devices (Izin Edar/AKL) with MoH or related bodies.
• Review and compile dossiers for registrations and data requests.
• Prepare product specs for government registrations and electronic catalogs.
• Handle OSS and E-Report systems and CDAKB audits.
• Issue Spare Parts Certificates for instrument maintenance.
• Review product labeling for regulatory compliance.
• Collaborate with Marketing on approved directives.
• Draft specs with Product team for electronic catalogs and registrations.
• Prepare monthly renewal/registration status reports to MoH.

Skills

Good English

Regulatory concepts

Teamwork

Strong integrity

Innovation mindset

Internal Audit CDAKB

E-report OSS familiarity

Education

Bachelor’s in Pharmacy, Biology, Chemistry or related

Job description

Registration Officer / Regulatory Affairs

Requirements:

• Minimum education of Bachelor’s (S1) in Pharmacy, Biology, Chemistry or related fields
• Preferably with at least 1 year of working experience in a similar position / Regulatory Affairs (preferably in medical devices/Alkes distribution)
• Good English communication skills
• Understanding of basic Science, Molecular, and Biochemistry concepts
• Excellent service orientation, high integrity, strong performance, teamwork skills, and innovative mindset
• Understanding of CDAKB - Internal Audit
• Familiar with E-report system and OSS System

Key Responsibilities:

• Registering medical devices (Izin Edar/AKL) with the Ministry of Health or other related government institutions
• Reviewing, preparing, translating, and compiling dossiers/documents required for medical device registration and additional data requests from Kemenkes
• Preparing and compiling product specification data for registration with government agencies and the E-Catalog system
• Handling OSS System, E-Report System and Audit CDAKB
• Issuing Certificate of Spare Parts (Surat Keterangan Sparepart) to support instrument maintenance
• Reviewing product labeling and ensuring all registration documents are valid and compliant with regulation standards
• Formulating plans together with the Marketing team based on approved directives
• Drafting specifications alongside the Product team for electronic catalog needs and product registration
• Preparing monthly summary reports for planned/renewal registrations and submitted products to Kemenkes
• Performing other duties assigned by superior

Benefits :

• Competitive base salary.
• BPJS Kesehatan and BPJS Ketenagakerjaan
• Transportation and travel allowance.
• Excellent career development opportunities within a fast-growing and dynamic organization.
• A supportive, collaborative, and transparent work environment that encourages innovation, teamwork, and continuous learning.

Note: Position placement is located in South Jakarta.

About PT Biomedikal Scientific Indonesia

PT Biomedikal Scientific Indonesia was established in Jakarta in January 2020. The company specializes in the distribution of medical devices, with a strong focus on laboratory diagnostic equipment and solutions.

As the exclusive principal and authorized distributor of Hologic and DiaSorin in Indonesia, we are committed to delivering innovative, high-quality diagnostic technologies that support healthcare professionals and improve patient outcomes across the country.

Our Vision

To become a leading and competitive medical device distribution company, recognized for excellence and quality throughout the Asia-Pacific region