Associate Director Regulatory Affairs - CDX (Remote)
Posted on: September 20, 2022
We are seeking an Associate Director Regulatory Affairs for our
Morrisville, NC site. This position will provide strategic and
tactical support to the Companion Diagnostics Development Team. The
incumbent will establish and execute the regulatory strategies,
lead FDA pre-submission package development and subsequent meetings
and author final product submissions. The incumbent is required to
provide guidance to assure that all regulatory submissions are
planned, communicated and executed per regulatory and business
requirements. In addition, this position serves as a subject matter
expert on various regulations and coordinates regulatory issue
resolution through the use of internal resources, regulatory
agencies, and outside consultants as needed. Requires the ability
to provide solutions based on their own knowledge and industry
experience base. Education: Required: Bachelor's degree in a
relevant scientific discipline. Preferred: Master's, or Ph.D.
degree in a scientific discipline. Experience: Minimum 7 years
experience developing regulatory strategies and supporting FDA
submissions of in vitro diagnostic (IVD) products with evidence of
FDA meetings, IDE, 510k, and/or PMA submissions.
- Demonstrated expertise in all phases of IVD product development
including design control, regulatory package documentation and GMP
- Regulatory knowledge of Submission/registration types and
requirements of GxPs (GCPs, GLPs, GMPs). 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, Cary , Associate Director Regulatory Affairs - CDX (Remote), Executive , Morrisville, North Carolina
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