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Regulatory Affairs Project Leader

Santa Clara, CA 95054

Posted: 05/22/2024 Employment Type: Contract Job Number: 604665 Is job remote?: No Country: United States

Job Description

  • 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 and external stakeholders.
  • High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict.
  • Prior regulatory experience in the medical device, food, dietary supplement or pharmaceutical industry is strongly preferred, but not required.
  • 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 manage and track broad and strategic projects.
  • Ability to communicate effectively in writing crisp briefings and issue analysis.
  • Demonstrated ability to work effectively in a team environment.
  • Responsible for tracking 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.

  • Bachelor's degree required, Masters degree preferred

  • Minimum of 3 years experience

  • Knowledge of US and/or Canadian regulation relating to product and/or device clearance (FDA)

Pay Rate Range: $40-52/hr. Salary will be commensurate with experience 
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About Santa Clara, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area around Santa Clara, California. Located in the heart of Silicon Valley, this region offers unparalleled growth opportunities in tech, innovation, and beyond. With attractions like Levi's Stadium, the Santa Clara Convention Center, and the nearby California's Great America theme park, there's always something exciting to do. Indulge in the diverse culinary scene, catch a show at the Triton Museum of Art or the historic Santa Clara Theatre, or cheer for the San Francisco 49ers at Levi's Stadium. Discover why Santa Clara is the perfect place to elevate your career and enjoy a rich blend of culture and charm!

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