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)