at DivIHN Integration, Inc in Hoffman Estates, Illinois, United States
Job Description
For further inquiries regarding the following opportunity, please contact our Talent Specialists
Meghna | 224 369 4230/mparwar@divihn.com
Title: Regulatory Specialist I
Location: Des Plaines, IL
Duration: 8 Months
Description:
Exempt/Non Exempt: Non Exempt
Years Experience:
- 0-2 years regulatory experience and/or relevant industrial experience typically with a quality, product-development/support, or scientific affairs function
- Must have 1-2 years of experiences in Medical Device Reg Affairs
Skills:
- Knowledge of regulations and standards affecting IVDs and/or biologics
- 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
Education:
- BA Degree Required
- 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.
- Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
- 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
