Deskripsi Pekerjaan
We are seeking a highly skilled and detail-oriented PJT (Penanggung Jawab Teknik) and Management Representative to join our team in Batang. In this critical role, you will be the primary liaison between our medical device operations and the Indonesian Ministry of Health, ensuring full compliance with national and international quality standards.
As our Management Representative, you will lead the implementation and maintenance of our Quality Management System, specifically focusing on ISO 13485 and CPAKB (Cara Pembuatan Alat Kesehatan yang Baik). The ideal candidate possesses a deep understanding of the Indonesian medical device regulatory landscape and has a proven track record in streamlining registration processes. You will play a pivotal role in ensuring our products meet safety and efficacy benchmarks, fostering trust with regulators, and maintaining our operational license in Indonesia.
If you are a regulatory affairs professional with a passion for compliance and a strategic mindset, we invite you to apply and contribute to our commitment to excellence in the healthcare sector.
Tanggung Jawab
- Manage and maintain the Quality Management System (QMS) in accordance with ISO 13485 and CPAKB standards.
- Act as the official Penanggung Jawab Teknik (PJT) representing the company to the Ministry of Health (Kemenkes).
- Lead the end-to-end medical device registration process, including document preparation and submission via the NIAK/Kemenkes portal.
- Oversee internal and external audits to ensure ongoing compliance with regulatory requirements.
- Monitor and update the company on changes to Indonesian medical device regulations and guidance.
- Manage post-market surveillance activities, including handling complaints and reporting adverse events.
- Coordinate with cross-functional teams (Production, QA/QC, and Supply Chain) to ensure quality standards are met at every stage.
Kualifikasi
- Bachelor’s degree in Engineering, Pharmacy, Biology, or a related field relevant to medical device regulation.
- Minimum of 3-5 years of professional experience in Regulatory Affairs within the medical device industry.
- In-depth knowledge of ISO 13485 and CPAKB certification requirements.
- Proven experience in handling medical device import/distribution licenses and registration with the Indonesian Ministry of Health.
- Excellent interpersonal and communication skills for stakeholder management and government liaison.
- Fluent in both Indonesian and English (professional proficiency).
- Strong analytical skills with a high level of attention to detail and ability to interpret complex regulations.
- Experience in conducting internal quality audits is highly preferred.