Regulatory Affairs Analyst

Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the following :

Job Description

• Keeps abreast of medical device regulatory procedures, medical device safety standards and changes in global regulations.
• Strong working knowledge of FDA regulations, UK, EU, ISO13485, Brazil, Australia, China, Japan, Canada, and Rest of World
• Compiles all materials required in submissions, license renewal and annual registrations to FDA, Health Canada, China NMPA, and other international authorities.
• Supports global product registrations, including the compilation and maintenance of regulatory dossiers, technical documentation, and country-specific submission materials.
• Performs device classification assessments in accordance with regulatory frameworks in the U.S., Canada, EU, China, and other global markets
• Maintains strong understanding of country-specific documentation and regulatory expectations for product submissions, compliance, and import / export.
• Prepares and provides Certificates of Compliance, Declarations of Conformity, and other supporting compliance documents for internal and external stakeholders.
• Participates in post-market surveillance, GMP compliance, 3rd party audits, inspections, reviews and approves advertising and promotions materials.
• Recommends changes for labeling, manufacturing, marketing, and usability protocols for medical device regulatory compliance.
• Participate as team member to plan, develop, and implement regulatory strategy throughout the medical device product lifecycle.
• Reviews and approves design outputs.
• Uses regulatory information and knowledge to integrate regulatory perspectives into the organization, its policies, and procedures.
• Reviews, approves, and recommends changes for labeling, manufacturing, marketing, and test protocols for regulatory compliance and / or approval.

Required Skills and Experiences

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