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Sr. Director of Regulatory Affairs (Future Opening- January 2023)

Company: Labcorp
Location: Burlington
Posted on: November 13, 2022

Job Description:

SUMMARY OF DUTIES AND RESPONSIBILTIESThe ideal candidate for this position would have extensive experience managing complex submissions and technical files (instrumentation, software and reagents) for US FDA 510(k) and EU CE mark products in accordance with regulatory requirements. Additionally, the candidate would demonstrate strong leadership skills and experience in working with various teams and colleagues on these activities. Their experience and knowledge helps provide guidance and direction along with legal and outside counsel. Further, the candidate will have extensive experience with the processes and procedures for bringing medical device product(s) and lab developed tests through the design control process from feasibility to launch. 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 activities which lead to and maintain domestic and international regulatory approval to market devices or tests or changes that may have regulatory implications.PRIMARY RESPONSIBILITIES

  • Helps to manage regulatory strategies and respond to changing requirements of diagnostic testing as well as develop implementation plans, in partnership with the project teams that achieve the Company's strategic goals, including in particular, establishing the Company's products and methods as standard of care in all target markets. Oversees implementation of all such plans to successful conclusion. 30%
  • Helps guide and assists with preparation and submission of files for regulatory clearances and approvals. 20%
  • Primary contact with regulatory agencies for regulatory compliance and global product registrations. 5%
  • Manages FDA submissions, including Pre-sub meeting planning, follow ups, and inspections. 10%
  • Provide leadership for currently marketed products and tests, e.g., review engineering changes, labeling, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements. 5%
  • 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. 30%QUALIFICATIONS
    • BS/BA degree in Science or related field; MS degree preferred or a focused degree in Regulatory Affairs.
    • 10+ years related regulatory experience
    • In-vitro diagnostic (reagents and instrumentation/software) experience preferred
    • In-depth understanding and experience with FDA, CE and ISO regulatory requirements relative to developing strategic regulatory development plans.
    • Strong understanding and experience with Design Control requirements is required
    • Experienced RA leader to core team(s) for product realization diagnostic projects
    • Demonstrated knowledge in the design, organization, negotiations, start-up and process of analytical and clinical trial requirements for successful regulatory approvals, both US and OUS
    • Experience with regulatory requirements of breakthrough device designations and benefit-risk assessments.
    • Strong team player This role is remote This job posting is for a future opening and will not be available until 1/1/2023 Labcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.For more information about how we collect and store your personal data, please see our Privacy Statement .

Keywords: Labcorp, Burlington , Sr. Director of Regulatory Affairs (Future Opening- January 2023), Executive , Burlington, North Carolina

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