Deskripsi Pekerjaan
OrbusNeich Medical Company Limited is a global leader in the medical device industry, dedicated to improving clinical outcomes through innovative technologies. We are currently seeking a detail-oriented and proactive Regulatory Affairs Specialist to join our team in Bekasi Barat. In this pivotal role, you will be the backbone of our regulatory operations in Indonesia, ensuring that our life-changing medical devices meet all local compliance standards while maintaining seamless communication with global regulatory bodies.
You will be responsible for navigating the complex landscape of Indonesian health regulations, managing product registration lifecycles, and fostering relationships with local health authorities. If you are passionate about medical compliance, process improvement, and patient safety, we invite you to contribute to our mission of providing high-quality healthcare solutions to the region.
Tanggung Jawab
- Prepare and manage comprehensive regulatory submission dossiers for medical device product registrations with the Ministry of Health (MOH) and other relevant Indonesian authorities.
- Coordinate with global regulatory teams to obtain and localize necessary documentation, technical files, and clinical evaluation reports.
- Monitor and analyze changes in the Indonesian regulatory environment to ensure company-wide compliance and proactive risk management.
- Maintain and update product registration licenses, including handling renewals, amendments, and notifications for product changes.
- Serve as the primary liaison between OrbusNeich and local regulatory agencies to ensure timely approval of marketing authorizations.
- Conduct internal audits and periodic regulatory assessments to maintain quality management system compliance.
- Provide regulatory expertise and support to internal departments, including Marketing and Quality Assurance, on labeling, promotional materials, and regulatory compliance matters.
Kualifikasi
- Bachelor’s degree in Pharmacy, Biomedical Engineering, Biology, or a related healthcare/scientific discipline.
- Minimum of 2-4 years of professional experience in Regulatory Affairs within the medical device or pharmaceutical industry.
- In-depth knowledge of Indonesian medical device regulations, including AKL/AKD registration processes.
- Proven track record of successful interaction with local regulatory authorities and experience in dossier compilation.
- Strong analytical skills with the ability to interpret complex legal and scientific documentation.
- Excellent verbal and written communication skills in both Indonesian and English.
- High level of integrity, meticulous attention to detail, and ability to manage multiple projects under tight deadlines.