We provide clients with unparalleled FDA/ISO Regulatory consulting, Quality Systems support, Point-of-Care Analyzer Training services, and Market Research & Go-to-Market guidance. We work with both large and small companies, manufacturing and distributing medical devices and in vitro diagnostic products and instruments. Want to join one of the top up-and-coming Regulatory Advisory companies? Read on!

***Provide regulatory guidance to study sponsors and IVD medical device manufacturers. Responsible for the overall planning and direction of clinical affairs and regulatory activities. Develops and implements strategies in a collaborative environment between colleagues and clients with the goal of successful regulatory submissions.***

• New Client/Sponsor on-boarding including attending client conferences, defining project scope and development of project proposals.
• Development of U.S. Food and Drug Administration (FDA) Pre-Submission, Informational Meeting or Determination Meeting Submissions.
• Assist in the creation of Clinical and Analytical Study Protocols, Informed Consent Forms (ICFs), Study Database, and Data Collection Forms in conjunction with assigned Project Managers.
• Assist with Institutional Review Board (IRB) submissions in conjunction with assigned Project Managers.
• Development, compilation, review and submission of Regulatory Filings such as FDA 510(k), de novo and PMA submissions, Health Canada Licensure, EU Technical Files, etc.
• Interaction with regulatory agencies and Sponsors throughout the submission and review processes.

MORE!:

• Bachelor's degree in a health care or other scientific discipline or educational equivalent.
• 5-10 years Clinical Trial Management and/or Regulatory Affairs experience.
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and HIPAA guidelines.
• Understanding of U.S. Food and Drug Administration (FDA) laws and guidance.
• Understanding of Health Canada Licensing Requirements and the EU IVDR.
• Understanding of IRB guidelines and Common Rule.
• 15-20% Travel including local, within U.S and outside of the US.