Specialist, Regulatory Affairs

SYSMEX ASIA PACIFIC PTE. LTD.
  • Job Category
    Healthcare / Pharmaceutical, Manufacturing, Sciences / Laboratory / R&D
  • Job level
    Junior Executive
  • Contract type
    Permanent
  • Location
    East
  • Salary
    S$3000 - S$3800

Job Description

Job Description & Requirements


Key Job Purpose:

  • Dossier preparation & product registration submission to HSA, leading to timely introduction of new products and responsible for supplemental filings for any changes
  • Assisting in data/information gathering & dossier compilation for product registration submission & other related licenses for Sysmex Asia Pacific affiliates & distributors including progress monitoring & follow-ups.
  • Provide regulatory support, update, advisory & knowledge sharing to Sysmex Corporation in Japan & Sysmex affiliates and distributors in order to remain in compliance with the government regulatory requirements in Asia Pacific.

Responsibilities:

  • Prepare & submit product registration documentation & other relevant licences’ application and ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements that lead to timely approval of new product registration in Singapore
  • Notify and update Health Science Authority (HSA) of any change of particulars / documents related to product registration
  • Manage adverse event and field safety corrective action reporting to HSA within the stipulated timeline
  • Ensure changes to the approved products are timely submitted to HSA as required
  • Maintain product approvals and dealer’s licences
  • Maintain product registration record and product registration database to ensure proper documentation and record filing
  • Maintain the knowledge and awareness of current applicable regulations and standards
  • Support business partners in new product registration, renewals and amendments
  • Support Sales, Marketing and Supply Chain Management in all regulatory related areas

Requirements:

  • Diploma in Medical Science or equivalent
  • Min 6 months experience in regulatory affairs or 1 year in a science/technical role in the health care industry (R&D, Clinical or other technical function)
  • Knowledge of Medical Device Regulation in Singapore and Asia Pacific
  • Basic computer knowledge & application
  • Customer focused with excellent communication and interpersonal skills
  • Responsible, team player, keen to learn
  • Ability to manage and prioritize multiple projects and tasks
  • Travel requirement: up to 20% per year in Asia Pacific region

Closing on 24 Sep 2021