Overview

• Salary

  3,500 SGD ~ 5,000 SGD

• Industry

  Healthcare & Medical

• Job Description

  Our client is a Medical Devices company and is now looking for a Regulatory Affairs Specialist.
  You will be reporting to Regulatory Affairs Manager
  
  【 What you will be doing 】
  ■Regulatory application, Compliance
  - Responding to company policy and company requirements, proposing strategic regulatory application and carrying it out.
  - Assess regulatory requirements and develop regulatory strategies for the qualifications of new products in ASEAN, Australia and New Zealand.
  - Compile technical files, test reports and documentation 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 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.
  
  ■Post-marketing activities
  - Coordination with the relevant people (Sales/Marketing, HQ-QA) and report to authorities if necessary.
  
  ■Collection of Regulatory information
  - 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 understanding of the importance of company policy and company requirements.
  - Regarding schedule change, report upper-rank personnel and people involved in timely manner.
  
  ■Industrial activity
  - Participate in industrial activities and negotiate with authorities.
  
  ■Others
  - Follow your supervisor’s instructions.