About this role
Support regulatory submissions and product registrations for medical devices and IVDs with authorities like HSA, FDA, and EU IVDR. Maintain and improve the Quality Management System (QMS) while ensuring compliance through audits and documentation control.
Requires a Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field. Candidates must have at least 2 years of relevant experience in Regulatory Affairs or Quality Assurance within the medical device or IVD industry.
What they're looking for
Regulatory AffairsQuality AssuranceProduct RegistrationQMS MaintenanceISO 13485GDPMDSEU IVDRFDA QSR
Frequently asked questions
What does a Regulatory Affairs & Quality Assurance Executive at CorDx do?
Support regulatory submissions and product registrations for medical devices and IVDs with authorities like HSA, FDA, and EU IVDR. Maintain and improve the Quality Management System (QMS) while ensuring compliance through audits and documentation control. Requires a Bachelor's degree in Life Science…
What skills does this Regulatory Affairs & Quality Assurance Executive role need?
Key skills for this role include Regulatory Affairs, Quality Assurance, Product Registration, QMS Maintenance, ISO 13485, GDPMDS.
How much does a Regulatory Affairs & Quality Assurance Executive at CorDx pay?
The employer did not list a salary for this role. Most similar Singapore roles publish their band on the job page.
Is this Regulatory Affairs & Quality Assurance Executive role remote, hybrid, or on-site?
This role is on-site, based in Singapore.
How do I apply for this Regulatory Affairs & Quality Assurance Executive role?
You can apply directly on CorDx's careers page. ApplyLah can tailor your résumé and cover letter to this exact role in seconds first.