Apoteker/Regulatory Officer (Alat Kesehatan & PKRT) - Tangerang, Banten

Join KOTRA as a Regulatory Officer specializing in Medical Devices and Pharmaceuticals, Kosmetik, dan Rumah Tangga (PKRT)! This is a unique opportunity to work closely with Indonesia’s regulatory authorities to ensure compliance, streamline import procedures, and contribute to the safety and quality of healthcare products in Indonesia. Based in Tangerang, Banten, you’ll be part of a dynamic team dedicated to upholding the highest standards in the pharmaceutical and medical device industries.

As a Regulatory Officer at KOTRA, you will play a crucial role in monitoring and enforcing regulations related to medical devices, pharmaceuticals, kosmetik, dan PKRT. Your daily tasks will involve reviewing documentation, conducting site inspections, and collaborating with stakeholders to ensure compliance with national and international standards. With a salary range of Rp 12,000,000 - Rp 20,000,000 per bulan, this position offers a competitive remuneration package and the chance to make a meaningful impact in the healthcare sector.

📋 Tanggung Jawab Pekerjaan

• Monitor and enforce regulations related to medical devices, pharmaceuticals, kosmetik, dan PKRT.
• Review and evaluate documentation, including import permits, registration certificates, and technical documents.
• Conduct site inspections to ensure compliance with regulatory standards.
• Collaborate with stakeholders, including manufacturers, distributors, and regulatory authorities.
• Develop and implement compliance programs to ensure adherence to regulations.
• Provide technical support and guidance to ensure the safe and effective use of medical devices and pharmaceuticals.
• Participate in regulatory workshops, conferences, and training programs.
• Maintain accurate and up-to-date records of regulatory activities.

🎓 Kualifikasi & Syarat

• Bachelor’s degree in Pharmacy, Medicine, or a related field.
• At least 3 years of experience in regulatory affairs, pharmaceuticals, or medical devices.
• Strong knowledge of Indonesian regulatory requirements for medical devices, pharmaceuticals, kosmetik, dan PKRT.
• Familiarity with international regulatory standards and guidelines.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in English and Bahasa Indonesia.
• Valid professional certification in regulatory affairs or a related field.

🛠️ Keahlian

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