Regulatory Affairs Manager

Regulatory Affairs Manager

Varex Imaging Corporation is a leading innovator, developer, and manufacturer of X-ray imaging component solutions, which includes X-ray tubes, digital flat panel detectors, software, and other key components of X-ray imaging systems. With a 65 year history of successful innovation, you will find our components in countless medical, industrial, and security imaging applications worldwide. Our mission states that through the talent of our people and vision of customers, we help improve and save lives throughout the world by making the invisible visible. Our values of Excellence, People, Innovation, and Customer are foundational to our success in upholding our mission. We cannot make the invisible visible and uphold our mission without our EPIC employees, who deliver cutting edge technology globally, consistently pursue the highest quality standards, engage in a diverse and ethical workforce, inspire innovation, and showcase a customer mindset. We strive every day to make a difference in the lives of both our customers and theirs.

Oversees and directs all product regulatory operations activities. Develops and implements strategies for earliest possible approvals of phase 1 through phase 4 market submissions. Provides counsel to and manages the global regulatory team. Ensures timely preparation of organized and scientifically valid applications in collaboration with engineering teams. Provides expertise in translating regulatory requirements into practical, workable plans. Interacts with regulatory agencies around the world. Selects, develops and evaluates personnel to ensure the efficient operation of the function.

SPECIFIC FUNCTIONS

• Performs all required management responsibilities including but not limited to: implementing the company's policies, programs, and guidelines; ensuring employee productivity and growth; managing resources; knowing Varex’s business; and maintaining functional, technical, and external market awareness necessary for managing immediate organization.
• Prepare and maintain an annual Regulatory Submission Schedule and corresponding safety file reports.
• Partner with engineering and sales functions to ensure the timely completion of actions related to product introductions or on-market changes
• Measure, monitor, and report metrics to ensure system effectiveness and efficiency and implement updates/changes as necessary to meet changing regulatory and business needs.
• Host and interface with various government agencies, private companies, and consultants (such as US FDA, ANVISA, BSI, EU MDR, etc.) related to regulatory audits/inspections and assist with the timely response to any findings.
• Develop, establish, monitor, and report on both corporate and departmental quality objectives, metrics, and goals.
• Promote and ensure companywide quality system compliance with all applicable national and international standards and regulations.
• Perform other duties as assigned.
• Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, and high-achieving team member
• Establishes the regulatory strategy for each new product introduction, approves product and facility changes impacting the regulatory product technical filings, project manages the on-market registrations and provides timely updates to the cross-functional groups.

Required Skills and Knowledge

• Ability to lead people
• Possess strong analytical skills in Regulatory Intelligence gathering
• Familiarity with MS Office, ETQ, SAP/ERP and other databases is a plus.
• Proficient in the regulatory submission process within design controls to include product environmental compliance
• Able to read and interpret regulations, technical drawings and specifications with support from engineering teams.

Required Certifications and Training

• ​RAPS certification a plus; Green Belt or Black Belt training a plus

Experience Level with Business Tools

• Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint.
• Experience with SAP or equivalent ERP product and productivity software desired.

Education and Experience

• Bachelor’s degree in life sciences or engineering discipline
• 5 years of specific experience in medical device submissions across multiple regulatory agencies, 510(k) preferred, EU MDR preferred, and other international jurisdictions.
• 5 years of management experience for global direct reports