We are seeking a competent, detail-oriented Regulatory Officer to ensure that all products we distribute are properly registered, legally compliant, and fully aligned with applicable medical device regulations.
Responsibilities
- Manage the registration process for new products, renewal of marketing authorizations (NIE/AKD/AKL), and amendments to medical device licensing documents.
- Prepare, verify, and ensure the completeness and accuracy of all registration documents, including the Product Information Document (DIP) and other supporting documents, prior to submission to the regulatory authority.
- Upload product documents, monitor publication status, and maintain product data in the LKPP e-Catalog system.
- Monitor changes in medical device regulations issued by the Ministry of Health and other relevant authorities, and assess their impact on the company.
- Maintain systematic records of all regulatory documents, certificates, and product licenses to ensure document traceability for audits, procurement processes, and customer requirements.
- Assist in coordinating with principals, vendors, and distributors to obtain the technical documentation and certificates required for product registration.
- Prepare and submit periodic reports to the relevant authorities through the e-Report Alkes system and other reporting platforms, as well as prepare internal licensing status reports for management.
Qualifications
- Education: Minimum Diploma (D3) or Bachelor's Degree (S1) in Pharmacy, Chemistry, Biology, or a related field. Preferred: Licensed Pharmacist with a valid STRA.
- Experience: Minimum 1–2 years of experience in Regulatory Affairs, preferably handling imported medical devices.
Technical Competencies
- Strong understanding of the medical device registration and licensing process with the Indonesian Ministry of Health (AKD, AKL, and NIE).
- Familiar with the preparation of the Product Information Document (DIP) and other regulatory documentation.
- Knowledge of CDAKB, IDAK, and administrative requirements for imported medical devices.
- Good command of spoken and written English for communication with overseas principals.
- Proficient in Microsoft Office and document administration.
Personal Attributes: Detail-oriented, resourceful, well-organized, able to work under deadlines, and familiar with the characteristics of medical device products.
Email Subject: Regulatory Officer_Your Name
*Only shortlisted candidates will be contacted for the next stage of the recruitment process.
