Regulatory Affairs Analyst

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Summary

Varex Imaging Regulatory Affairs Analyst participates in the 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

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:

• 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.
• Compiles and maintains technical files for medical device products
• Participates in hosting/assisting with external audits from Notified Bodies, and Product Safety Agencies

Required Skills and Experiences

• Bachelor’s Degree in life sciences, engineering, regulatory compliance,
• 2+ years of experience in regulatory compliance in the medical device industry and medical device safety standards.
• 2+ years of experience driving related medical device safety standards into design requirements.
• 2+ years of experience completing multiple submissions across health authorities.
• Experience with Class I, II, and/or III medical devices and industrial products (including experience determining device classifications globally).
• Proven track record of preparing and managing regulatory submissions (e.g., FDA 510(k), Health Canada License Applications, EU Technical Files, NMPA dossiers, etc.).
• Experience supporting product registrations and certifications across multiple international markets.
• Microsoft Office/ERP/QMS Software competency

Time Type:

Full time

Job Type:

Regular

Work Shift:

N/A

Pay Rate Type:

Salary

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.