Lowongan Regulator Affair (RA) & Penanggung Jawab Teknis (PJT) di PT Ict Worldwide Indonesia

About the company :

• The working venue is in Jakarta Selatan

 Job responsibilities :

• Prepare product dossier compilation, or country specific requirements for the regulatory submission to the Regulatory Authoritis / MoH in a timely manner
• Actively follow up (consultation) with Regulatory Authorities  / MoH on the regulatory submission and approvals
• Perform registration of new products, variations, and re-registration of products to obtain registration number getting approval immediately
• Ensure the completion and compliance of documents related to obtain advertising registration approval in timely manner
• Analyze registration documents in accordance with ACTD and in accordance with the registration requirements
• Create monitoring of registration status of products and submission of certification
• Implement regulatory affairs activities well-documented, according to provisions of the legislation in force, and coordinate issues with multi stakeholder
• Liaise with manufacturer to ensure they deliver the service as stated in the agreement in a timely manner (such as providing documents for products registration)
• Provide thoughtful & accurate comments to the manufacturer during the document review of the new products pertaining to document content
• To build good working relationship with Regulatory Authorities / MoH, regulatory consultants and manufacturer
• Responsible as PJT for the distribution of medical devices
• Understanding of CDAKB and its application and completeness of administrative documents
• Applying CDAKB quality management system standards
• Establishment of company quality guidelines together with HR
• Accompany the MoH audit team and coordinate actions/responses to findings
• Planning and participating in the implementation of external audits (provider: expedition, manufacturer, outsourcing and others) based on the related contract
• Evaluate and authorize all written procedures and other documents related to/impact on product quality, including amendments
• The process of receiving, storing, and distributing medical devices in accordance with procedures
• Ensure stock taking is done every 6 months to ensure the accuracy of stock between physical and system data
• Handling and reporting Kejadian Tidak Diinginkan (KTD) / Unwanted Event and Field Safety Corrective Action (FSCA) to MoH
• Responsible for the process of implementing the recall of medical devices (recall)
• Reporting distribution documents to the MoH on time (E-Report reporting every month to MoH and stock taking every 6 months)
• Create and be responsible for the Product Information List / Daftar Informasi Produk (DIP)

 Job requirements :

• Minimum Apothecary
• Bachelor Of Pharmachy Education
• Fresh Graduate / Minimum one (1) year of experience PJT in Medical Devices/ Pharmacy
• Having active STRA/SERKOM/SIPA is a must
• Understanding of CDAKB
• Having CDAKB Certification is Preferred
• Able to work cooperate with expatriates in under pressure and tight deadline
• Experiance in the process of Receiving, Storing and distribution madical devices
• Strong verbal and written communication skills
• Proactive, professional attitude, self-motivated
• Able to speak English is must