Deskripsi pekerjaan
Join our growing R. A. team in Batam and play a key role in ensuring compliance with global med dev regulations, including ISO 13485, EU MDR, FDA etc
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.
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
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
Informasi lowongan
- Tipe pekerjaan
- Full-time
- Gaji
- Negosiasi