One of our Japanese Medical Instrument clients is looking for Japanese Speaking Regulatory Affairs.
JOB RESPONSIBILITIES
- Understand company policy.
- Cope with unusual cases promptly and follow up when problems occur.
- Responding to company policy and company requirements, propose and carry out strategic regulatory application.
- Assess regulatory requirements and develop regulatory strategies for the qualifications of new products.
- Compile technical files, test reports and documentations necessary for regulatory submissions.
- Maintain up to date documentation and archival regulatory submissions and related documents according to the company’s documentation policies and procedures.
- Maintenance of GDPMDS and ensure staff’s compliance to SOPs.
- Coordination with internal/external peoples for application/query response document procurement.
- Coordination with the other govt. authorities as and when required and instructed by upper rank personnel.
- Cope with unusual cases promptly and follow up when problems occur.
- Responding to company policy and company requirements, propose and carry out strategic regulatory application.
- Assess regulatory requirements and develop regulatory strategies for the qualifications of new products.
- Compile technical files, test reports and documentations necessary for regulatory submissions.
- Maintain up to date documentation and archival regulatory submissions and related documents according to the company’s documentation policies and procedures.
- Maintenance of GDPMDS and ensure staff’s compliance to SOPs.
- Coordination with internal/external peoples for application/query response document procurement.
- Coordination with the other govt. authorities as and when required and instructed by upper rank personnel.
Team / Schedule Management (If you are becoming assistant manager or above position)
- Coordination with the relevant peoples (Sales/Marketing, GHQ-QA) and report to authorities if necessary.
- 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 importance of company policy and company requirements.
- Regarding schedule change, report upper rank personnel and people involved in timely manner.
- 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.
- Develop budgets and perform budget control if required.
- Make proposals to reduce cost.
- 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 importance of company policy and company requirements.
- Regarding schedule change, report upper rank personnel and people involved in timely manner.
- 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.
- Develop budgets and perform budget control if required.
- Make proposals to reduce cost.
Reporting line: Regional Regulatory Affairs Manager (Working at Japan HQ)
Head counts at Singapore office: 7
Head counts at Singapore office: 7
JOB REQUIREMENT
➢ Advanced-level of Japanese proficiency as reporting manager is Japanese (JLPT N1 or equivalent)
➢ Willing to pursue next career as Regulatory Affairs (Non experienced personnels are welcomed!)
➢ Eyes for details to read and check the related documents such as practical law
➢ Good communication skills to liaise with internal and external parties
➢ Once or twice a year business trips may be required to visit countries in charge to attend seminars
➢ Willing to pursue next career as Regulatory Affairs (Non experienced personnels are welcomed!)
➢ Eyes for details to read and check the related documents such as practical law
➢ Good communication skills to liaise with internal and external parties
➢ Once or twice a year business trips may be required to visit countries in charge to attend seminars
OTHER INFORMATIONS
Working days: Monday - Friday
Working hours: 9:00 a.m. - 6:00 p.m.
Salary Range: SGD 4,500 - 6,000 (Depend on your experience)
Bonus: Yes (AWS + VB / Min 2 months in total)
Annual Leave: TBD
Salary Range: SGD 4,500 - 6,000 (Depend on your experience)
Bonus: Yes (AWS + VB / Min 2 months in total)
Annual Leave: TBD
Medical Leave: 14 days
Other benefits: Able to work from home up to 3 working days per week / need to work more than 10 working days per month in the office
Interviews: More than twice
Other benefits: Able to work from home up to 3 working days per week / need to work more than 10 working days per month in the office
Interviews: More than twice
Do note that we will only be in touch if your application is shortlisted.
Thank you for your understanding.
JAC Recruitment
1 Raffles Place #42-01, One Raffles Place, Tower 1, Singapore 048616
Tel: 6323 4779 / 6411 0377 Email: jac@jac-recruitment.sg
EA Licence No: 90C3026
EA Personnel: R23117850
EA Personnel Name: Nakamura Yuta
1 Raffles Place #42-01, One Raffles Place, Tower 1, Singapore 048616
Tel: 6323 4779 / 6411 0377 Email: jac@jac-recruitment.sg
EA Licence No: 90C3026
EA Personnel: R23117850
EA Personnel Name: Nakamura Yuta
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