Regulatory Affairs Specialist – Maternity Cover

Blood

Regulatory Affairs Specialist at Blood handling product registrations and compliance in Indonesia's medical-device sector. Collaborating with internal teams to ensure regulatory adherence and operational efficiency.

Posted 7/27/2026part-timeJakarta • 🇮🇩 IndonesiaMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Act as Blood’s Technical Responsible Person (TRP) in Indonesia and the day-to-day regulatory point of contact for our medical-device portfolio during the cover period.
Manage new product registration (AKL) submissions with Kemenkes (MOH) — including any applications in progress at handover.
Prepare and file change notifications for existing product registrations with Kemenkes.
Handle end-to-end import regulatory documentation to keep commercial shipments clearing smoothly, including Import Report, LHVIU, PERTEK, and PI (Persetujuan Impor).
Maintain CDAKB compliance across the distribution operation, and own QMS setup/compliance and internal/external audits (e.g. ISO 13485, CE, GDPMD, CDAKB).
Lead the IDAK / CDAKB / regulatory workstream for the 3PL: ensure our 3PL warehouse is fully IDAK/CDAKB compliant.
Liaise with supply chain to ensure product-label compliance on commercial shipments.
Work with Kemenkes and other authorities, certification bodies and auditors, and coordinate internally with Operations, Supply Chain, Production, R&D and QA to resolve regulatory queries.
Stay informed on changes in regulatory laws and work with internal stakeholders to mitigate business impact.
Monitor registration status, renewals, and any regulatory deadlines falling within the cover period, and flag risks early.
Maintain regulatory records and documentation so the returning specialist can pick up seamlessly.
Handle any other regulatory-related matters as required by the company and management.

Requirements

What you’ll need

Highly preferred — one of the following degrees or diplomas:
- DIII/S1 Farmasi / Apoteker (Pharmacy / Pharmacist)
- DIII/DIV Analis Farmasi / Analis Farmasi & Makanan (Pharmaceutical Analyst / Pharmaceutical & Food Analyst)
- S1 Kimia (Chemistry)
- S1 Teknik Kimia (Chemical Engineering)
- S1 Teknik Biomedik (Biomedical Engineering)
At least 3 years of Regulatory Affairs experience in Indonesia covering product registrations and life-cycle management (baseline).
6+ years and an independent/consulting track record is strongly preferred.
Proven, first-hand track record in Indonesian medical-device RA — not oversight or advisory only. You have personally:
- Filed new product registrations (AKL) with Kemenkes
- Prepared and submitted change notifications to Kemenkes
- Handled import regulatory documentation: Import Report, LHVIU, PERTEK, PI
- Worked within CDAKB and IDAK frameworks — specifically handling IDAK/facility changes.
Good understanding of the relevant regulatory, legal and import environment in Southeast Asia, especially Indonesia.
Able to operate fully independently with minimal supervision and a short handover.
Based in Jabodetabek.
Fluent in Bahasa Indonesia and English (written and spoken).

Benefits

Comp & perks

Great team - We have a diverse team across Asia-Pacific where you will get to work alongside bright and driven individuals with proven experience in high-growth environments in both startups and MNCs alike.
Strong backing - We are funded and backed by top angel investors in SE-Asia.
Working flexibility - We believe in a hybrid working environment, where our team can benefit from the best advantages of working from home, working from office, and anywhere in between.