Regulatory Affairs
Allvacon
- Jakarta, IndonesiaMZ-D2, Jalan T. B. Simatupang, Kebagusan Kel., Pasar Minggu, Jakarta, DKI Jakarta, IndonesiaJakartaDKI JakartaIndonesiaIndonesia
- Full timeFULL_TIME
Expired 16 days ago
2024-12-04T17:00:00+00:00Job closed.
Job Description
- Plan the registration of medical devices or other required licensing documents in accordance with the set targets and regularly report the progress of each registration activity to the supervisor;
- Compile the necessary documents, conduct a self-assessment of the completeness of the registration files according to registration requirements, and archive the registration documents;
- Communicate with the principal or relevant parties to produce the documents requested by the Ministry of Health of the Republic of Indonesia;
- Maintain communication and a good relationship with the Ministry of Health to obtain updates on regulations or other relevant matters;
- Responsible for conducting regular audits of the warehouse to ensure compliance with regulations and SOPs;
- Monitor all regulations related to products and company licenses as a medical device distributor;
- Monitor regulatory updates;
- Maintain the archives of registration documents and the registration database;
- Ensure that all company-owned products meet the standards and are suitable for distribution;
- Upload products to the e-catalog;
- Develop training modules for the use of medical devices.
Minimum Qualifications
- Bachelor's degree in Pharmacy or Biomedical Engineering from a reputable university;
- Minimum of 1-2 years of experience in registration (Medical Devices);
- Understanding of regulations related to registration (e.g., CDAKB);
- Ability to independently prepare registration documents;
- Proficient in English;
- Possess good interpersonal skills;
- Highly initiative, innovative (creative), and detail-oriented;
- Strong sense of responsibility and teamwork;
- Good personal relationships & communicative;
- Ability to collaborate effectively with both internal and external parties.
Jobs Summary
- Job Level
- Entry Level / Junior, Apprentice
- Job Category
- Health and Medical
- Educational Requirement
- Bachelor's degree graduate
- Recruiter response to application
- Once in a while
- Office Address
- Jalan T. B. Simatupang, Kebagusan Kel., Pasar Minggu
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About Allvacon
PT. Allvamed Nuvacon Adigana aims to bring better Arthroscopy products and services in Indonesia. Today, patients and surgeons are challenged to achieve high-quality arthroscopy solutions because of insufficient instruments, expensive equipment, and a lack of service satisfaction. The Allvacon brand as a service product aims to make arthroscopic surgery truly accessible to everyone. We are here to facilitate surgeons in providing the highest quality care for patients through innovative and of course cost-effective equipment. By leveraging affiliations with global suppliers, PT. Allvamed Nuvacon Adigana strives to provide genuine value to patients with our affordable, comprehensive and best-of-breed services. PT Allvamed Nuvacon Adigana will expand its services throughout Indonesia and beyond. To achieve these goals, we need a passionate, creative and energetic management team to develop this opportunity to be bigger and more widespread.