Location: Eugene, OR 97401
Duration: 6-7 Months
Purpose of the position/Job Summary:
The primary purpose of this position is to assist in the establishment and maintenance of regulatory compliance. In large part, this is accomplished through submission, organization and maintenance of regulatory records.
Scope & Impact:
Research involving human participants, and the development and use of medical device requires the timely and precise organization of regulatory documents. It is imperative that regulatory documentation reflect the changing requirements of regulations and interpretation of those changes.
• Submit and track regulatory documents to Institutional/Independent Review Boards (IRB), sponsors, and other regulatory bodies
• Maintain regulatory study binders and any associated clinical and regulatory records as deemed necessary
• Prepare for and handle study monitor visits
• Support regulatory meetings and trainings, including generate and maintain meeting minutes
• Assist with submission of the 510(k) applications, annual reports or other correspondence to the Food & Drug Administration (FDA)
• Maintain clinical trial registration sites
• Assist with standard operating procedures (SOP) and working instruction documents (WID) creation, updates, and maintenance
• QC of regulatory functions (e.g. consent form review)
• Additional responsibilities as deemed necessary by supervisor
• Required: Minimum of bachelors degree. The individual must be highly organized and detail oriented, while having the ability to assess the critical areas needed for documentation and record-keeping. This position requires an individual with strong inter-personal communication skills.
• Preferred: Experience in regulatory related field. Knowledge of GCP, ISO 13485, and FDA quality system regulation and other regulatory requirements commonly used in clinical and medical device settings.
APN Software Services INC
39899 Balentine Drive, Suite 385, Newark, CA 94560