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Associate Director, Regulatory Affairs

Company: NeoGenomics Laboratories
Location: Aliso Viejo
Posted on: June 6, 2021

Job Description:

Are you motivated to participate in a dynamic, multi-tasking environment? Do you want to join a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to dive deeper into this opportunity.

We believe in career development and empowering our employees. Not only do we provide career coaches internally, but we offer many training opportunities to expand your knowledge base! We have highly competitive benefits with a variety HMO and PPO options. We have company 401k match along with an Employee Stock Purchase Program. We have tuition reimbursement, leadership development, and even start employees off with 16 days of paid time off plus holidays. We offer wellness courses and have highly engaged employee resource groups. Come join the Neo team and be part of our amazing World Class Culture!

NeoGenomics is looking for an Associate Director, Regulatory Affairs who wants to continue to learn in order to allow our company to grow.

Now that you know what we're looking for in talent, let us tell you why you'd want to work at NeoGenomics:

As an employer, we promise to provide you with a purpose driven mission in which you have the opportunity to save lives by improving patient care through the exceptional work you perform. Together, we will become the world's leading cancer reference laboratory.

Position Summary:

he Associate Director, Regulatory Affairs is responsible for assigned regulatory affairs activities supporting NeoGenomics Clinical and Pharma Services Departments.

Responsibilities:

  • Ensure regulatory compliance to local, state and federal guidelines and regulations pertaining to NeoGenomics Laboratories, Inc.
  • Assist organizational departments with regulatory review of items including laboratory protocols and test reports
  • Create, edit and manage regulatory affairs and quality SOPs
  • Attend weekly project team meetings as required for regulatory affairs support
  • Maintenance of regulatory affairs projects tracker
  • Manage IRB applications, IRB submissions and IRB correspondences
  • Assist with the following regulatory submissions pertaining to NeoGenomics clinical and pharmaceutical projects:
  • Investigational Device Exemptions (IDEs)
  • NSR/SR Risk Designation
  • Pre-market Approval (PMA) Applications
  • Humanitarian Device Exemption (HDE)
  • Institutional Review Boards (IRBs)

  • Other duties as assigned by the Director of Regulatory Affairs

Requirements:

Education: Bachelor's Degree required; M.S./M.A. in Physical or Life sciences preferred

Experience: 7+ years in the regulatory affairs environment within a clinical laboratory, healthcare setting or IVD manufacturer including the following:

  • Class III IVDs
  • Regulatory submissions in China and Singapore
  • CDER, CBER and/or CDRH submissions
  • IRB requirements and IRB submissions
  • Oncology experience is highly preferred

Qualifications:

  • Excellent medical/scientific writing skills
  • Understanding of molecular laboratory testing (i.e. NGS, WES)
  • Understanding of clinical pathology
  • Must be familiar with phase I, II, III clinical study designs
  • Must be familiar with design controls, FMEA and risk management of medical devices
  • Understanding of companion diagnostic IVDs
  • Familiar with IVDR (EU)
  • Must be familiar with CAP/CLIA requirements
  • Understanding of 21-CFR-50, 21-CFR-56, 21-CFR-812, 21-CFR-820
  • Must be familiar with Good Clinical practices (GCPs)
  • Familiarity with eQMS systems (i.e. MasterControl)
  • Ability to manage and coordinate several ongoing projects simultaneously
  • Understand of laboratory developed tests (LDTs) and FDA regulated IVDs

All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Keywords: NeoGenomics Laboratories, Aliso Viejo , Associate Director, Regulatory Affairs, Other , Aliso Viejo, California

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