Abbott Diagnostics Medical Co., Ltd. supply variety of rapid diagnostics products globally.
The Regulatory Affairs Specialist provides a support role to the physical and legal manufacturing site at Chiba, Japan.
This position provides regulatory expertise in the IVD / Medical Device area to execute regulatory activities with cross functional on site or global teams including but not limited to: IVDR teams, EU Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, etc. to ensure all internal and external requirements are met prior to and after product release.
Main responsibilities
- Implement regulatory activities to ensure
- regulatory requirements compliance and earliest possible introduction of product(s)
- regulatory impacts for post market change management activities
- Global registration of change associated with the key project
- Update of technical file and labelling associated with the key project
- Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications.
- Provide technical expertise for site certifications and quality management system audits.
- Provides input and comment on regulations and standards which may affect division products.
- Implement processes and activities involved with obtaining and maintaining product release authorization and release of product to specified geographies.
- Implement Regulatory Affairs process and activities within the Medical Device Reporting / vigilance process; and report timely to regulatory authorities, notified body, and related stakeholders or organizations.
- Implement labeling process and activities during product life cycle.
Must to have
- Strong English skills
- (3) years of experiences of IVD / Medical Device Regulatory Affairs
- Bachelor’s Degree (BA/BS) or equivalent experiences.
Nice to have
- Building IVDR Technical Files
- Overseas IVD / Medical device registration/change submission activities
- Quality assurance (ISO 13485) relevant experiences
- Project relevant experiences
