Varex Imaging

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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

Roles and Responsibilities

• Keeps abreast of medical device regulatory procedures, medical device safety standards and changes
• Strong working knowledge of FDA regulations, guidance documents, 93/42/ECC (MDD), EU 2017/745 (EU MDR), ISO14971, ISO13485, MDSAP, and other global regulatory requirements and standards
• Compiles all materials required in submissions, license renewal and annual registrations to FDA, Health Canada, China CFDA, and others
• Helps drive applicable requirements of IEC 60601-1 and related medical device safety standards into design requirements
• Provides technical support, regulatory guidance, and oversight for Safety (UL) and EMC testing including EMC and Safety test plans, working with test lab/test sites, review and approve test reports
• 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
• Participates 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
• Adverse event determination and reporting to FDA, EU, and other countries
• Helps determine and facilitate Field Actions and Recalls
• Compiles Technical Files for Europe
• Participates in hosting/assisting with external audits from Notified Bodies, customers, and FDA

Minimum Requirements

• Bachelor’s Degree in life sciences, engineering, regulatory compliance, or:
• 5+ years of experience in regulatory compliance in the medical device industry and medical device safety standards
• 5+ years of experience driving related medical device safety standards into design requirements
• 5+ years of experience completing multiple submissions across health authorities
• Experience establishing or sustaining quality management systems
• Microsoft Office/ERP/QMS Software competency

Preferred Requirements

Master’s Degree in life sciences, engineering, regulatory compliance; plus;

• 3+ years of experience in regulatory compliance in the medical device industry and medical device safety standards
• 3+ years of experience driving related medical device safety standards into design requirements
• 3+ years of experience completing multiple submissions across health authorities
• Software experience in a regulated industry

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.