Regulatory Affairs Specialist

1 week ago

Des Plaines, United States CareerBuilder Full time

Job Title: Regulatory Affairs Specialist
Location: Des Plaines, Illinois, United States
Duration: 08 Months

Job Description:
Description:
Must have 1-2 years of experiences in Medical Device Reg Affairs
Have working knowledge in EU MDR Have working knowledge in Regulatory Change Assessments Have working knowledge in US and EU medical device submissions Work cross-functionally and in a matrixed environment Have experience with continuous improvement activities.
Duties:. Assist the strategy implementation and operations for regulatory affairs activities, including preparing documents and deliverables to supporting change notifications and submission activities , license renewals etc.
Working knowledge of the regulations including EU MDR would be helpful in understanding the regulatory requirements for IVDR implementation.
Identify opportunity for regulatory affair processes and drive changes to completion. This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
Additionally Provide tracking, reporting, and presentation to management for the project activities.
Regulatory experience and/or 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.
Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
Duties: Responsible for implementing and maintaining the effectiveness of the quality system.
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.

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