Medical Licensing & Compliance Officer - BPOM/AKL/CDAKB/IDAK Registration Specialist

Dirga Bahari Perkasa is seeking a dedicated Medical Licensing & Compliance Officer to join our team in Jakarta Utara. In this critical role, you will be responsible for managing and ensuring regulatory compliance for healthcare products in Indonesia, focusing on BPOM (Badan Pengawas Obat dan Makanan), AKL (Izin Alat Kesehatan), CDAKB (Certificate of Distribution of Active Ingredient), and IDAK (Izin Distribusi Alat Kesehatan) registrations. This position offers a unique opportunity to work with cutting-edge technology and industry-leading software, ensuring seamless operations and adherence to regulatory standards.

As a Medical Licensing & Compliance Officer, you will be at the forefront of regulatory compliance, working closely with cross-functional teams to streamline the registration process. You will handle various aspects of medical licensing, including application submissions, document management, and compliance audits. This role is perfect for professionals with a strong background in regulatory affairs and a passion for ensuring the safety and efficacy of healthcare products.

📋 Tanggung Jawab Pekerjaan

• Manage and coordinate the registration process for BPOM, AKL, CDAKB, and IDAK registrations.
• Ensure compliance with all regulatory requirements and standards.
• Prepare and submit application documents for medical product registrations.
• Conduct compliance audits and monitor ongoing regulatory activities.
• Maintain and update regulatory databases using specialized software.
• Provide training and support to internal teams on regulatory compliance.
• Collaborate with legal and technical teams to address regulatory issues.
• Stay updated with the latest regulatory changes and industry trends.

🎓 Kualifikasi & Syarat

• Bachelor's degree in Pharmacy, Regulatory Affairs, or a related field.
• Minimum of 5 years of experience in regulatory affairs, particularly in the pharmaceutical or medical device industry.
• Certification in regulatory affairs (e.g., ICH-GCP, ISO 13485, or similar) is a plus.
• Strong knowledge of Indonesian regulatory requirements for medical products.
• Proficiency in using regulatory management software such as MedReg, eSubmission, or similar.
• Excellent communication and interpersonal skills.
• Ability to work independently and manage multiple tasks in a fast-paced environment.
• Fluency in both English and Indonesian languages.

🛠️ Keahlian

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