Regulatory Pharmacist

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Ensure implementation and maintenance of CDAKB requirements, IDAK compliance, and applicable medical device regulations throughout the Company's operations.

• Oversee receiving, storage, handling, and distribution activities of medical devices while ensuring appropriate storage conditions, product traceability, and compliance with distribution requirements in collaboration with the Operations Manager.

• Collaborate closely with Regional Quality Assurance to maintain and manage the Quality Management System (QMS), including CDAKB and ISO 9001 compliance, quality documentation, SOP updates, records, document control activities, and other compliance-related documentation, ensuring alignment with applicable regulatory and company requirements.

• Collaborate closely with Regional Quality Assurance to investigate and manage product complaints, nonconformities, deviations, Corrective and Preventive Actions (CAPA), product recalls, and Field Safety Corrective Actions (FSCA), including the timely reporting of serious incidents to the Ministry of Health (MoH), in accordance with applicable regulatory and quality requirements.

• Support internal and external audits, regulatory inspections, and communications with the Ministry of Health and other regulatory authorities, serving as the primary liaison between LifeWave and the health authorities (eg., MOH).

• Collaborate with and support Regional Quality Assurance in investigating and managing product complaints, deviations, corrective and preventive actions (CAPA), product recall activities, and Field Safety Corrective Actions (FSCA) as required.

• Conduct and coordinate CDAKB, quality, and compliance-related training activities for employees and relevant stakeholders.

• Monitor regulatory updates and with APAC RA supervisor on regulatory requirements, compliance obligations, and continuous improvement initiatives related to quality management and distribution compliance.

• Provide support to the Country Manager on regulatory compliance matters, office coordination, and other administrative matters as required.

• Support the maintenance of operational documentation, training records, and related coordination activities as required.

REQUIREMENTS

• Minimum Diploma (D3) in Pharmacy, Electromedical Engineering, or other equivalent qualifications acceptable under applicable regulations.

• Eligible to be appointed as a Penanggung Jawab Teknis (PJT) in accordance with applicable Indonesian regulations.

• Experience in medical device, healthcare, pharmaceutical, regulatory, quality assurance, or related functions is preferred.

• Knowledge of CDAKB, IDAK, ISO 9001 quality management system, and applicable regulatory requirements.

• Strong communication, organizational, problem-solving, and coordination skills.

• Proficiency in Microsoft Office applications.

• Good written and verbal communication skills in Bahasa Indonesia and English.

• Attention to detail, responsible, independent, a self-starter with a high sense of urgency.