Our client, a medical device manufacturing company, is looking for a (Japanese speaking) Regulatory Affairs Specialist. The successful candidate will be working with Class C or D medical devices.
Job Responsibilities:
Regulatory application, Compliance
- Responding to company policy and company requirements, propose strategic regulatory application and carry it out.
- Assess regulatory requirements and develop regulatory strategies for the qualifications of new products in the company's territories.
- Compile technical files, test reports and documentations necessary for regulatory submissions.
- Maintain up-to-date documentation, archival regulatory submissions, and related documents according to the company’s documentation policies and procedures.
- Maintenance of GDPMDS and ensuring staff’s compliance with SOPs.
- Coordination with internal/external people for application/ query response document procurement.
- Coordination with the other govt. authorities as and when required and instructed by upper-rank personnel.
- Collect and compile regulatory information/updates and report to upper-rank personnel and people involved.
Schedule management
- Manage schedules for regulatory submissions and make adjustments with an understanding of the importance of company policy and company requirements.
- Regarding schedule change, report upper-rank personnel and people involved in a timely manner.
Post-marketing activities
- Coordination with the relevant people (Sales/Marketing, GHQ-QA) and report to authorities if necessary.
Team Management
- Managing team, planning and goal setting for team.
- Work allocation, monitoring and review of team performance.
- Provide guiding assistance to the members.
- Supporting team members with training and development activities.
Budget control
- Develop budgets and perform budget control if required.
- Make proposals to reduce cost.
Industrial activity
- Participate industrial activities and negotiate with authorities.
Others
- Follow your supervisor’s instructions and other ad-hoc duties as assigned.
Job Requirements:
- Able to communicate using Japanese language with Japan counterparts and HQ
- JLPT 3 certified and above
- Good communication skills to liaise with internal and external parties.
- Eyes for details to read and check the related documents such as practical law.
- Once or twice a year business trips may be required to visit countries in charge to attend seminars.
Interested applicants, please send your resume to Tiffany (R1104633) [email protected] with email subject header “Job Application for (Japanese speaking) Regulatory Affairs Specialist - TK” for immediate processing.
We regret that only shortlisted candidates will be notified. Other applications will be updated to our database for future job opportunities.
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Thank you for your kind understanding and co-operation.
Pasona Singapore Pte Ltd
EA License No:90C4069
R1104633
Koh Jia Wen
