Regulatory Specialist I
DivIHN (pronounced divine) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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For further inquiries regarding the following opportunity, please contact our Talent Specialists
Meghna
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.
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Estimated Salary: $20 to $28 per hour based on qualifications.
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