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Regulatory Affairs Specialist
3 weeks ago
**Responsibilities**:
- Assess regulatory requirements and discuss regulatory strategies with the related staff for the qualifications of new products in Asia Pacific.
- Compile technical files, test reports and documentations necessary for regulatory submissions in the above countries.
- Maintain up to date documentation and archival regulatory submissions and related documents according to the company’s documentation policies and procedures.
- Maintenance of medical device related licenses and ensure staff’s compliance to SOPs.
- Coordination with the other govt. authorities as and when required and instructed by upper rank personnel.
- Support RA/QA activities for the above countries based on instructions from management
- Collect and compile regulatory information/updates and report to upper rank personnel and people involved.
- Manage schedules for regulatory submissions and make adjustments with understanding of importance of company policy and company requirements.
- Regarding schedule change, report upper rank personnel and people involved in timely manner.
**Job Requirements**:
- Degree in related discipline
- At least 3-4 years of relevant experience in Regulatory Affairs
- Detail-oriented and able to cope with fast-paced environment