Registration Officer / Regulatory Affairs

Requirements:

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

Key Responsibilities:

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

Benefits :

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

Skills: Medical Products, Medical Device QA, Medical Equipment Repair, Teamwork, Customer Service, Medical Policy, Microsoft Office, Medical and Healthcare, Medical Devices, Medical Device QC