Associate Director Regulatory Affairs

Job Overview:

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/Qualifications:

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 manufacturing. Regulatory knowledge of Submission/registration types and requirements of GxPs (GCPs, GLPs, GMPs).