Regulatory Affairs (Maternity Cover)

Hello. We’re Blood. Our purpose is to revolutionize periods. Who are we? Blood is a challenger consumer brand that creates game-changing period care products for all who bleed. Our focus on deeply understanding and caring for our users drives our product innovation and material design, which enables us to invent products that are both high performing and also better for the body. Blood is the creator of the world’s first Sanitary Pad made from Corn, and is the parent brand of MenstruHeat (menstrual cramp relief) and the Blood Menstrual Cup. Our products are sold across Malaysia, Indonesia, and Singapore, both direct-to-consumer online and in more than 9,000 retail stores - making more than 12 million periods better so far. Today was good. Tomorrow will bleed better. Who we’re looking for: This is a hands-on, 4-6 months part time maternity cover role. You’ll step into live registrations, in-flight applications, ongoing import and distribution compliance, and keep everything moving without disruption. You must be able to walk in with minimal ramp-up, the handover window is roughly 1–2 weeks. You must be based in Jabodetabek, necessary for authority visits, submissions and shipment coordination. We're looking for someone with a strong desire to make a real impact. You will have a key role and exposure in delivering a compliant Blood business to help extend our reach to our next million users as a period care challenger brand. Working closely with internal teams and external bodies, you will plan, drive and implement regulatory affairs strategies to comply with local government requirements and company standards in the Indonesian market. What you will do: 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 — coordinating the required CDAKB inspection/certification, and updating IDAK and registration records so distribution authorization stays unbroken. 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 What we require: 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 — see Level of expertise below 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 (e.g. adding or changing a warehouse, onboarding a 3PL, or a CDAKB premises inspection), not just steady-state compliance 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) Nice to have: Prior experience in the beauty, retail, and/or pharmaceutical industry Experience with sanitary / personal-care or consumer medical-device products specifically Good working relationship with country health authorities (Kemenkes / MoH) ISO 13485 / QMS familiarity Experience managing a warehouse or 3PL from the regulatory side Prior fractional or contract RA work for principals/distributors (i.e. used to parachuting into an existing setup) Driven & independent, and open to taking on diverse responsibilities in a dynamic environment Make a difference - As a fast-growing consumer start-up, joining us is both an opportunity to make a real difference in the lives of millions of women, as well as experience unique learnings first-hand as we scale up 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.