Description

To apply to a Varex Imaging position, please create an account and sign-in.CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account.<h2>Summary</h2>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:<h2>Job Description</h2>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:<ul><li>Keeps abreast of medical device regulatory procedures, medical device safety standards and changes in global regulations.</li><li>Strong working knowledge of FDA regulations, UK, EU, ISO13485, Brazil, Australia, China, Japan, Canada, and Rest of World</li><li>Compiles all materials required in submissions, license renewal and annual registrations to FDA, Health Canada, China NMPA, and other international authorities.</li><li>Supports global product registrations, including the compilation and maintenance of regulatory dossiers, technical documentation, and country-specific submission materials.</li><li>Performs device classification assessments in accordance with regulatory frameworks in the U.S., Canada, EU, China, and other global markets</li><li>Maintains strong understanding of country-specific documentation and regulatory expectations for product submissions, compliance, and import/export.</li><li>Prepares and provides Certificates of Compliance, Declarations of Conformity, and other supporting compliance documents for internal and external stakeholders.</li><li>Participates in post-market surveillance, GMP compliance, 3rd party audits, inspections, reviews and approves advertising and promotions materials.</li><li>Recommends changes for labeling, manufacturing, marketing, and usability protocols for medical device regulatory compliance.</li><li>Participate as team member to plan, develop, and implement regulatory strategy throughout the medical device product lifecycle.</li><li>Reviews and approves design outputs.</li><li>Uses regulatory information and knowledge to integrate regulatory perspectives into the organization, its policies, and procedures.</li><li>Reviews, approves, and recommends changes for labeling, manufacturing, marketing, and test protocols for regulatory compliance and/or approval.</li><li>Compiles and maintains technical files for medical device products</li><li>Participates in hosting/assisting with external audits from Notified Bodies, and Product Safety Agencies</li></ul>Required Skills and Experiences<ul><li>Bachelor’s Degree in life sciences, engineering, regulatory compliance,</li><li>2+ years of experience in regulatory compliance in the medical device industry and medical device safety standards.</li><li>2+ years of experience driving related medical device safety standards into design requirements.</li><li>2+ years of experience completing multiple submissions across health authorities.</li><li>Experience with Class I, II, and/or III medical devices and industrial products (including experience determining device classifications globally).</li><li>Proven track record of preparing and managing regulatory submissions (e.g., FDA 510(k), Health Canada License Applications, EU Technical Files, NMPA dossiers, etc.).</li><li>Experience supporting product registrations and certifications across multiple international markets.</li><li>Microsoft Office/ERP/QMS Software competency</li></ul>Time Type:Full timeJob Type:RegularWork Shift:N/APay Rate Type:SalaryAll 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.