About this role
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 kevynhuang@recruitexpress.com.sg Consultant: Huang Jingsheng Kevyn (R1333338) Recruit Express Pte Ltd (99C4599)
What they're looking for
NegotiationFDARemediationRegulatory Compliance
About Recruit Express Pte Ltd
Industry: Administrative & support servicesWebsite ↗
Frequently asked questions
What does a 6Mths Contract Regulatory Affairs Specialist - Up To $4.5K (Medical Device Mnc) #Hkh at Recruit Express Pte Ltd do?
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 author…
What skills does this 6Mths Contract Regulatory Affairs Specialist - Up To $4.5K (Medical Device Mnc) #Hkh role need?
Key skills for this role include Negotiation, FDA, Remediation, Regulatory Compliance.
How much does a 6Mths Contract Regulatory Affairs Specialist - Up To $4.5K (Medical Device Mnc) #Hkh at Recruit Express Pte Ltd pay?
This role lists a salary of S$4,000 – S$4,500 per month.
Is this 6Mths Contract Regulatory Affairs Specialist - Up To $4.5K (Medical Device Mnc) #Hkh role remote, hybrid, or on-site?
The listing is based in Islandwide. Check the posting for remote or hybrid options.
How do I apply for this 6Mths Contract Regulatory Affairs Specialist - Up To $4.5K (Medical Device Mnc) #Hkh role?
You can apply directly on Recruit Express Pte Ltd's careers page. ApplyLah can tailor your résumé and cover letter to this exact role in seconds first.
