This Regulatory Affairs Specialist is responsible for the preparation and support of regulatory submissions and product registrations required to market in vitro diagnostic (IVD) devices in the U.S. with future expansion into international markets. Experience with molecular infectious disease products and/or point of care and over-the-counter devices highly desirable. Requires strong technical writing skills, problem solving, attention to detail and ability to collaborate across department. May provide leadership by assigning work and resolving complex problems.
Coordinate, prepare, and follow up with FDA Premarket Notification [510(k)] submissions, CLIA Waiver applications and over-the-counter applications in a timely manner.
Represent Regulatory Affairs in product life cycle and design teams by providing regulatory guidance throughout the product development and lifecycle.
Review clinical and non-clinical protocols and reports to ensure appropriate data for regulatory submissions and regulatory compliance.
Review/approve labeling, promotional and advertising materials to ensure regulatory compliance.
Participate in post-market activities, including medical device reporting (MRD/vigilance) and field actions. Provide regulatory guidance and assist with reporting to FDA and notified bodies, as needed.
Support the Vice President of Regulatory and Clinical Affairs in acting as liaison with FDA regarding product clearance and notified bodies for CE marking.
Prepare regulatory documentation required for international registration (e.g., technical files for CE marking) with appropriate collaboration with various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
Education and/or Experience
B.S. degree or higher in a life science or technical discipline, preferably in molecular biology, biology, chemistry or medical laboratory science
1-3 years of Medical Device or related industry experience
Working knowledge of industry consensus standards and FDA guidance
Proficient in using Microsoft Office
Strong technical writing skills
Strong communication and project management skills