Deskripsi pekerjaan PJT & Management Executive PT Human Assist Indonesia
We are hiring a Penanggung Jawab Teknis and Management Representative to oversee medical device registration, regulatory compliance, and post-market activities in Indonesia. The role will work closely with regulatory authorities, internal quality and technical teams, and government agencies to ensure compliance with applicable medical device regulations and quality standards. This role located in Batang Industrial Park, Central Java.
Job Requirements:
- Indonesian nationality, with fluent in English both spoken and written.
- Bachelor's degree or above in Pharmacy; CPAKB certification is preferred.
- At least 3 years of experience in medical device regulatory registration, with strong knowledge of Indonesia's medical device regsitration processes and regulatory framework.
- Familiar with ISO 13485, MDR, FDA, and related standardss.\
- Good communication skills, with the abillity to effectively engage with government officials and maintain strong relationships
Job Responbilities:
- Responsible for product registration, variation, and renewal.
- Assist in establishing and maintaining a quality management system in complience with ISO 13485 and Indonesia CPAKB requirements, ensuring that system documentation meets registration and regulatory inspection requirements.
- Responsible for post-market surveillance of products, including adverse event reporting, product recalls, and field safety corrective actions, and maintain compliant communication with regulatory authorities.
- Work closely with technical, production, and quality departments to ensure that product design changes, labeling, and instructions for use comply with registration requirements.Establish and maintain good relationships with the Indonesian Ministry of Health, medical device regulatory authorities, customs, and inspection and quarantine agencies; support local audits and ensure timely updates on regulatory policies
