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Regulatory Affairs SpecialistID:10046790

3,500 SGD ~ 5,000 SGDCentral, North
  • Job Function

    Medical & Healthcare > Others (Medical & Healthcare)
    Logistic > Purchase/Procurement,Logistic Coordinator/Executive
    Business Administration > General Affairs/Administration,Sales Coordinator

  • 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.

    - Follow your supervisor’s instructions.

  • Requirement

    【 What they are looking for 】
    - Relevant education or working experience in medical devices or a related field.
    - More than 3 years of regulatory application experience in the field of medical devices.
    - Experience in the product, business processes/procedures, regulatory frameworks and requirements.

  • Working Hour

    8:30 ~ 17:30

  • Benefit

    【 What they are offering 】
    - AWS
    - Variable Bonus (Depends on the Company and Individual Performance)
    - Annual Leave 14 days (Max 21 days)
    - Medical Insurance Include Dental
    - Dental Allowance S$150/year
    - Medical Allowance S$600/year

This job is closed

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