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

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 kevynhuang@recruitexpress.com.sg
• Consultant: Huang Jingsheng Kevyn (R1333338)
• Recruit Express Pte Ltd (99C4599)

Additional Information

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.

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