Sr Regulatory Specialist- Medical Device- Remote Opportunity

Location: Princeton, New Jersey, United States
Salary: competitive
Job Type: Contract
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Sr Regulatory Affairs Specialist- Full Remote Opportunity

Hours: Monday-Friday 8am-5pm

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.

Seeking:

  • Knowledge of US regulations and standards affecting IVDs
  • Experience as contributing author for US submissions

Offering:

  • Full Benefits- Health, Dental & Vision
  • 401K
Sthree US is acting as an Employment Business in relation to this vacancy.
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