Technical Regulatory Lead – IVD Medical Devices

PT. Biomedikal Indopharm Nusantara; Jakarta Utara; On-site; IDR 180,000,000 - 320,000,000; Full time

Job summary

PT. Biomedikal Indopharm Nusantara, a distributor of laboratory medical devices, seeks a PJT (Penanggung Jawab Teknis) to join our North Jakarta headquarters. The role focuses on regulatory registrations and licensing for IVD devices with the Indonesian Ministry of Health.

The candidate will manage CDAKB, CPAKB, AKD, TKDN, and ISO 13485 activities, prepare product certification documentation, and ensure ongoing regulatory compliance across distribution, warehousing, and audits.

Qualifications

• Bachelor's degree in Pharmacy; regulatory affairs or IVD experience preferred.
• Strong understanding of Indonesian MOH regulations (CDAKB, CPAKB, NIE, Certification) and TKDN/ISO13485.
• Experience with GMP, GDP, and medical device documentation.
• Proficient in MS Office and document management for regulatory submissions.
• Excellent written and verbal communication in Indonesian and English.

Responsibilities

• Register and license IVD medical devices with the Ministry of Health.
• Prepare, self‑assess, and submit CDAKB, CPAKB, AKD, TKDN, and ISO 13485 documentation.

Skills

Regulatory affairs

Documentation management

MS Office

Quality systems knowledge

Education

Bachelor's degree in Pharmacy

Tools

Photoshop

Canva

Adobe applications

Job description

PT. Biomedikal Indopharm Nusantara, a distributor of laboratory medical devices, seeks a PJT (Penanggung Jawab Teknis) to join our North Jakarta headquarters. The role focuses on regulatory registrations and licensing for IVD devices with the Indonesian Ministry of Health.

The candidate will manage CDAKB, CPAKB, AKD, TKDN, and ISO 13485 activities, prepare product certification documentation, and ensure ongoing regulatory compliance across distribution, warehousing, and audits.