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Regulatory Affairs Specialist

2 months ago

Santa Clara, United States GForce Life Sciences Full time

Regulatory Affairs Specialist- Santa Clara, CA

Must be able to work on a W2

Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.

Key Responsibilities:

Duties:

  • Assist in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel
  • Communicate issues to management through project management tracking and issue briefings
  • Maintain high visibility to internal and external stakeholders
  • Demonstrate a high level of effective verbal and written communication skills, including negotiation, influencing, and conflict management
  • Work constructively, decisively, and collegially with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs
  • Manage and track broad and strategic projects
  • Communicate effectively in writing crisp briefings and issue analysis
  • Work effectively in a team environment
  • Track and ensure timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities
  • Communicate regulatory requirements to project teams and internal customers effectively

Qualifications:

  • Bachelor's degree required in engineering or science, masters preferred
  • Minimum of 3 years of experience in regulatory affairs
  • Knowledge of US and/or Canadian regulations relating to product and/or device clearance (FDA) or with EU and other international medical device regulation submissions
  • Hands-on experience with 510k submissions, or PMA/s or US Annual report or CE Technical documentation preparation
  • Ability to negotiate, influence, and manage conflict
  • Prior regulatory experience in the medical device, food, dietary supplement, or pharmaceutical industry preferred, but not required
  • Ability to work constructively, decisively, and collegially with internal customers
  • Ability to manage and track broad and strategic projects
  • Demonstrated ability to write crisp briefings and issue analysis

Term & Start

  • 12-month contract with possibility to extend
  • FT, M-F 40hr/week
  • Pay Rate: $49-54/HR (98-108K Annually)
  • Onsite in Santa Clara, CA