This site uses cookies. To find out more, see our Cookies Policy

Regulatory Affairs Associate in Des Plaines at Collabera

Date Posted: 9/6/2018

Job Snapshot

Job Description

Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
Regulatory experience relevant industrial experience typically with a quality, product-development/support, or scientific affairs function Skills: Knowledge of regulations and standards affecting IVDs and/or biologics.
Supports manufacturing/operations day to day activities for change control. Provides consultation/advice to regulatory specialist for change control and product development. Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams. Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Handles regulatory activities involved in documentation, labeling, field support. Applies regulatory and technical knowledge to a wide variety of complex work assignments. Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports. Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

Job Requirements

Regulatory, Quality, Documentation, Submissions