Regulatory Affairs Manager

  • Location

    Singapore

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    S$6000 - S$8000 per annum

  • Contact:

    Jason Nathan

  • Contact email:

    jason.nathan@voltinternational.com.sg

  • Job ref:

    BBBH9651_1629444556

  • Published:

    4 months ago

  • Expiry date:

    2021-09-19

  • Consultant:

    #

My client is a global leader in the design of complex medical device products and now seek a Manger for RA. They are seeking for someone with an experience in EU regulation.

Responsibilities:

  • Assume responsibility as RA Manager to register, maintain and renew product / establishment licenses
  • Manage and ensure compliance on product registration and renewal activities
  • Provide regulatory advice on business strategy and manage RA projects and services
  • Perform yearly Post Market Assessment for products as required by regulations and standards
  • Perform 510K pre-market notifications for products registered in relevant countries.
  • Handle the specific product registration activities in SEA and new emerging markets
  • Ensure regulatory compliance by completing the appropriate filings and documentation pertaining to the company's product registration/approvals

Requirements:

  • Degree in life sciences, biotechnology or equivalent with at least 5 years 'experience in RA
  • Strong understanding of MDSAP, EU MDR 2017/745, MDD 93/42/EEC, ISO 13485 requirements and ISO 9001 requirements
  • Knowledge of related Regulatory and cGMP requirements
  • Stronghold in Product Registration, Trademark and CE Mark
  • Results-oriented, meticulous and a self-motivated team player

Please send your resume in WORD format by clicking the apply button below or contact Jason Nathan on +65 67011517 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R21101268 (Jason Nathan)