Job Description

One of our Japanese Medical Instrument clients, specialized in stainless steel wire ropes and terminal processed products 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 in AIS.
- 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.Reporting line: Regional Regulatory Affairs Manager (Working at Japan HQ)
Head counts at Singapore office: 7JOB REQUIREMENT\xe2\x9e\xa2 Advanced-level of Japanese proficiency as reporting manager is Japanese (JLPT N1 or equivalent)
\xe2\x9e\xa2 Willing to pursue next career as Regulatory Affairs (Non experienced personnels are welcomed!)
\xe2\x9e\xa2 Eyes for details to read and check the related documents such as practical law
\xe2\x9e\xa2 Good communication skills to liaise with internal and external parties
\xe2\x9e\xa2 Once or twice a year business trips may be required to visit countries in charge to attend seminarsOTHER INFORMATIONS
Working days: Monday - FridayWorking 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: TBDMedical 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 twiceDo 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#LI-JACSG
#countrysingapore

JAC Recruitment