Executive Director, Regulatory

Recognized as one of Forbes 2022 World’s Best Employers and named to Fast Company magazine’s list of 2021 Most Innovative Companies, Labcorp is seeking to hire a home-based Executive Director, Regulatory. The ideal candidate for this position would have extensive experience overseeing and managing the process and team for complex submissions and technical files (instrumentation, software and reagents) for US FDA 510(k) and EU CE mark products. Additionally, the candidate would demonstrate strong leadership skills and experience in working with various teams and colleagues on these activities. They will work collaboratively with legal and outside counsel, the National Office of Quality, the laboratories and the regulatory team. This candidate will be responsible to manage activities associated with regulatory approval of in vitro diagnostic medical devices and laboratory developed tests and responsible for overseeing the activities which lead to and maintain domestic and international regulatory approvals for devices or tests or changes that may have regulatory implications. They are not responsible for the writing of the bulk of the submissions or having expert knowledge of the regulations.

PRIMARY RESPONSIBILITIES

• Oversees implementation of regulatory related projects to successful conclusion.
• Helps guide and assists with preparation and submission of files for regulatory clearances and approvals.
• Manages FDA submissions, including Pre-sub meeting planning, follow ups, and inspections.
• Provide management around submissions for engineering changes, labeling, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.
• Manage submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings. May include LDT submission activities working closely with legal, the National Office of Quality, the laboratories and the regulatory team.

QUALIFICATIONS

• PhD degree in Science or related field
• 10+ years related experience
• Strong understanding and experience managing teams and projects
• Demonstrated knowledge in the design, organization, negotiations, start-up and process for successful projects that enable regulatory submissions
• Strong team player

Pay Range: $200,000-$230,000 base salary, plus bonus potential

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), and Company bonus where applicable. For more detailed information, please [Register to View] .

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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