6mths contract Regulatory Affairs Specialist - Up to $4.5K (Medical device MNC) #HKH

RECRUIT EXPRESS PTE LTD

  • Ensure regulatory compliance in Singapore and the Export Markets.
  • Compile registration dossiers for new product registrations or change notifications according to regulatory plan and local regulatory requirements.
  • Submit product registrations or change notifications to the relevant regulatory authorities and obtain approval timely.
  • Submit license renewals timely.
  • Assess impact of changes initiated by Product Owner and work closely with the supply chain, manufacturing and commercial teams to ensure no disruption to supply.
  • Provide internal stakeholders with regular updates throughout the registration process.
  • Monitor changes in the regulatory environment in order to formulate appropriate company response to the changes.
  • Report Field Safety Corrective Actions and Adverse Events to the Authority
  • Maintain regulatory databases or systems.

Requirements

  • Min Degree in any engineering or science course s
  • Min 2 to 3 years of regulatory experience in medical device

Interested candidates, please forward your resume to ***email_hidden***

Consultant: Huang Jingsheng Kevyn (R1333338)

Recruit Express Pte Ltd (99C4599)