Job Description
Full details about the role and requirements
Yukerja Summary
The Regulatory Affairs Specialist role at OrbusNeich Medical Company Limited is curated from JobStreet (category Kesehatan). Note the work location (West Bekasi, West Java) before applying. Yukerja.com is not the employer — applications are handled on the official source site.
Job Summary
The Regulatory Affairs Specialist is responsible for managing medical device registration activities and ensuring regulatory compliance in Indonesia. This role works closely with local, regional, and global stakeholders to prepare and submit regulatory dossiers, maintain product registrations, and support the introduction of new products to the market. The incumbent will monitor regulatory requirements, coordinate with the Ministry of Health (MOH) and relevant authorities, and contribute to maintaining compliance with applicable medical device regulations and quality system requirements. This position offers valuable exposure to both local and global regulatory affairs within a dynamic international medical device environment.
Key Responsibilities
Regulatory Registration & Submission
Prepare, compile, review, and submit regulatory dossiers for medical device registrations, renewals, variations, and amendments in Indonesia.
Coordinate product registration activities with the Indonesian Ministry of Health (MOH) and other relevant regulatory authorities.
Monitor registration timelines and proactively follow up with authorities to ensure timely approvals.
Regulatory Compliance
Ensure compliance with applicable Indonesian medical device regulations and regulatory requirements.
Maintain regulatory licenses, certificates, and product registration records.
Monitor regulatory changes and assess their impact on existing products and business operations.
Cross-Functional Collaboration
Liaise with global and regional Regulatory Affairs teams to obtain technical documentation and registration support materials.
Work closely with Quality Assurance, Supply Chain, Manufacturing, and Commercial teams to support product launches and ongoing regulatory compliance.
Coordinate responses to regulatory authority queries and requests for additional information.
Documentation & Quality Support
Maintain accurate regulatory documentation and filing systems.
Support implementation and maintenance of Quality Management System (QMS) requirements related to regulatory activities.
Participate in audits and inspections when required.
Continuous Improvement
Identify opportunities to improve registration processes and regulatory efficiency.
Support special projects and other regulatory initiatives as assigned.
Requirements
Bachelor's Degree in Pharmacy, Biomedical Engineering, Life Sciences, Regulatory Affairs, or related disciplines.
Minimum 2 years of experience in Regulatory Affairs within the medical device, pharmaceutical, healthcare, or life sciences industry.
Hands-on experience with Indonesian medical device registration processes and MOH submissions is highly preferred.
Experience managing product registrations throughout the full product lifecycle is an advantage.
Familiarity with Indonesian medical device regulations and regulatory requirements.
Basic understanding of ISO 13485 and medical device Quality Management Systems.
Strong documentation, analytical, and organizational skills.
Ability to manage multiple projects and deadlines simultaneously.
Strong communication and stakeholder management skills.
Fluent in Bahasa Indonesia and English (written and spoken).
Mandarin/Chinese language capability will be an advantage.