Batam Regulatory Affairs Executive

Deskripsi Pekerjaan

Kualifikasi

• Bachelor's degree in a Science or Engineering discipline, preferably in Chemistry, Chemical Engineering, Pharmacy, or a related field
• Proficiency in written and spoken English is a must
• Minimum 3 years' experience in Regulatory Affairs or similar roles within a manufacturing industry (medical device, pharmaceutical, or other healthcare sectors preferred)
• Strong knowledge of chemistry, material science, and chemical compositions
• Demonstrate a strong understanding of medical device regulations and standards such as ISO 13485, MDR, FDA CPAKB, with a proven track record of maintaining compliance
• Experience conducting internal and external audits is highly desirable
• Experience supporting Halal certification and relevant compliance activities is highly desirable
• Experience supporting regulatory submissions and engaging with the Indonesian Ministry of Health and other international regulatory authorities is highly desirable
• Willing to be placed in Batam

Tanggung Jawab

• Maintain a deep understanding of medical device standards, especially ISO 13485, and the EU MDR (European Medical Device Regulations), FDA requirements and other national regulatory frameworks
• Support the implementation and ongoing compliance of the Unique Device Identification (UDI) system
• Manage and control quality documents of external origin to support regulatory compliance activities across the Batam and Perth sites
• Collaborate with Perth site to support the development and maintenance of risk management documentation and product classifications in accordance with applicable regulatory requirements
• Prepare the necessary technical documentation for regulatory submissions, including Technical Files, PMA submissions, CE documentation, and other regulatory dossiers as required
• Support Post-Market Surveillance (PMS) activities by collecting, analysing, and reporting post-market data, complaints, and adverse events to ensure timely and accurate submissions to regulatory authorities
• Collaborate closely with the Perth Regulatory Manager and cross-functional teams to support regulatory submissions and compliance projects by gathering, analysing, and maintaining required data and documentation