Regulatory Project Manager Polaris Project

Princeton, NJ
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Type: Contract

Category: Scientific & Clinical

Job ID: 158335

Date Posted: 01/08/2021


Job TitleRegulatory Project Manager Polaris Project

Contract Length:  6 mos

Number of Openings:  4

Job Description:

Education:

  • Bachelor's degree required, Masters degree preferred

 

Experience:

  • Minimum of 6 years experience

 

Skills:

  • Demonstrated experience clearing devices in US Duties: Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.
  • Communicates issues to management through project management tracking and issue briefings.
  • Position is highly visible to internal stakeholders.
  • High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict.
  • Prior regulatory experience with IVDs or medical devices is required.
  • Experience with CLIA waived products is a plus.
  • Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.
  • Ability to communicate effectively in writing crisp briefings and issue analysis.
  • Demonstrated ability to work effectively in a team environment.
  • Responsible for writing and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities. Responsible for effective communication of regulatory requirements to project teams and internal customers

 

 


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