Bachelor's degree in life sciences or related field
2 years experience in regulatory affairs or qa
Knowledge of hsa regulations and iso 13485
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ABIORES PTE. LTD. is seeking a Regulatory Affairs & Quality Assurance Executive in Singapore to support regulatory activities and ensure compliance with quality management systems for medical devices and IVDs. The ideal candidate will have a Bachelor’s degree in a related field and at least 2 years of relevant experience in the industry.
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Job Summary
The role involves supporting regulatory activities including preparation and submission of product registrations for medical devices and IVDs to HSA and other authorities.
Candidates will assist in maintaining and improving the Quality Management System (QMS) in accordance with ISO 13485, GDPMDS, and other applicable standards.
The position requires coordinating with cross-functional teams to ensure compliance with regulatory and quality requirements while supporting internal and external audits.
Matching Summary
Match Score: 75
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ABIORES PTE. LTD. is seeking a Regulatory Affairs & Quality Assurance Executive in Singapore to support regulatory activities and ensure compliance with quality management systems for medical devices and IVDs. The ideal candidate will have a Bachelor’s degree in a related field and at least 2 years of relevant experience in the industry.
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Skills & Requirements
Must-have
Bachelor's degree in Life Sciences or related field
2 years experience in Regulatory Affairs or QA
Knowledge of HSA regulations and ISO 13485
Nice-to-have
Familiarity with EU IVDR and FDA QSR standards
Experience with regulatory submissions and product registration
Understanding of QMS processes and CAPA procedures
Key Requirements
Bachelor's degree in Life Sciences, Biotechnology, or Biomedical Engineering
At least 2 years of relevant experience in Medical Device or IVD industry
Basic knowledge of HSA regulations, ISO 13485, and GDPMDS