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Regulatory Affairs Specialist

3 months ago

Santa Clara, United States SPECTRAFORCE Full time

Title: Regulatory Affairs Project Leader

Duration: 12 Months

Location: Santa Clara, CA 95054


Description:


Education: Bachelor's degree required, Masters degree preferred


Experience: Minimum of 3 years experience


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


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 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.