Collaborate with regulatory teams to secure product clearances
Coordinate and prepare regulatory submission documents for FDA, Health Canada, EU Competent Authorities, and other agencies
Act as Regulatory Affairs representative for BG Ultrasound
Support cross-functional teams during new product design and development phases
Lead global regulatory intelligence initiatives and contribute to regulatory strategies

5+ years of experience in medical device regulatory affairs
510(k) and EU MDR Technical Documentation authoring experience
Strong understanding of FDA QSR, ISO 13485, ISO 14971, IEC 62304 standards
Experience with software development life cycle, AI, data science, or software testing preferred
Bachelor’s/Master’s Degree in a science, engineering, or health-related discipline
RAPS certification is a plus
Willing to travel up to 10% based on business needs

Senior Regulatory Affairs Specialist

Key skills