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Varex Imaging is seeking a Regulatory Affairs Analyst to ensure compliance for medical and industrial x-ray products. The role involves collaboration across various teams and requires knowledge of international regulatory standards and experience in managing regulatory submissions.
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Job Summary
The Regulatory Affairs Analyst ensures compliance of medical and industrial X-ray products across global markets.
This role requires compiling materials for submissions to authorities like the FDA, Health Canada, and China NMPA.
The position involves participating in post-market surveillance, GMP compliance, and supporting external audits from Notified Bodies.
Matching Summary
Match Score: 75
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Varex Imaging is seeking a Regulatory Affairs Analyst to ensure compliance for medical and industrial x-ray products. The role involves collaboration across various teams and requires knowledge of international regulatory standards and experience in managing regulatory submissions.
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Skills & Requirements
Must-have
FDA regulations knowledge
ISO13485 compliance expertise
Global regulatory submission experience
Medical device classification assessment
Technical documentation compilation
Nice-to-have
Cross-functional team collaboration
Post-market surveillance participation
Audit preparation and support
Labeling and marketing review skills
Key Requirements
Bachelor's Degree in life sciences or engineering
2+ years experience in medical device regulatory compliance
Experience with Class I, II, and III medical devices
Proven track record of preparing regulatory submissions