Regulatory Affairs Specialist

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

Des Plaines, United States ProKatchers LLC 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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