Recruitpedia Pte. Ltd. is seeking a Regulatory Affairs Specialist for a leading medical devices manufacturer in Singapore. The role involves providing regulatory strategy, managing submissions, and ensuring compliance with international regulations
Job Summary
The role involves providing regulatory strategy and guidance to support product development and timely market launches.
Candidates will prepare and manage complex regulatory filings including US FDA 510(k) and EU MDR Technical Files.
The position requires maintaining product registration databases and ensuring adherence to international medical device regulations.
Matching Summary
Match Score: 85
Recruitpedia Pte. Ltd. is seeking a Regulatory Affairs Specialist for a leading medical devices manufacturer in Singapore. The role involves providing regulatory strategy, managing submissions, and ensuring compliance with international regulations.
Skills & Requirements
Must-have
4+ years regulatory affairs experience
US FDA 510(k) submission expertise
EU MDR Technical Files preparation
ISO 13485 standard knowledge
Global regulatory registration management
Nice-to-have
Experience with post-market vigilance reporting
Ability to support field safety corrective actions
Strong stakeholder advisory skills
Key Requirements
Bachelor's degree in Life Sciences or related field
Minimum 4 years of medical device regulatory experience
Familiarity with FDA product registration processes