Senior Regulatory Affairs Officer (Medical Devices)

  • Location

    Singapore

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    S$4000 - S$4500 per month

  • Contact:

    Abhik Damani

  • Contact email:

    abhik.damani@voltasia.com.sg

  • Job ref:

    BBBH9309_1621920299

  • Published:

    4 months ago

  • Expiry date:

    2021-06-24

My client is a global leader in the design of complex medical device products and now seek an experienced Regulatory Affairs Officer

Responsibilities:

  • Manage and ensure compliance on product registration and renewal activities of all countries where products are marketed.
  • Provide regulatory advice on company's business strategy and manage projects in the provisions of these regulatory affairs services.
  • Prepare and compile all necessary required application and technical documentation for Product Registration and Product License Listing
  • Perform the yearly Post Market Assessment for both contact lens and lens care products as required by regulations and standards.
  • Update and maintain Product Registration Profile according to the respective country regulations formats.
  • Ensure regulatory compliance by completing the appropriate filings and documentation pertaining to the company's product registration/approvals

Requirements:

  • Degree in Chemistry, Biotechnology or equivalent with 2-4 years' experience in Regulatory Affairs
  • Knowledge of ISO 13485, US FDA 21 CFR Part 820 QSR and other product registration regulations
  • Understanding of related Regulatory and cGMP requirements

Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).