Singapore Regulatory Affairs Specialist - JAC Recruitment Singapore

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: 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


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
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

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:
/ Email: -EA Licence No: 90C3026


EA Personnel:

R

EA Personnel Name:
Nakamura Yuta

#LI-JACSG

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