Regulatory Affairs Project Manager

2 weeks ago


Santa Clara, California, United States Intellectt Inc Full time

Position: Regulatory Affairs Project Manager

Company: Intellectt Inc

Location: Santa Clara, CA

Job Overview:

  • Education: A Bachelor's degree is mandatory; a Master's degree is advantageous.
  • Experience: At least 3 years of relevant experience is essential.
  • Skills: Familiarity with US and/or Canadian regulations concerning product and/or device approval (FDA) is required.

Key Responsibilities:

  • Collaborate in the formulation and execution of regulatory strategies and priorities alongside management, colleagues, commercial teams, and affiliate personnel.
  • Effectively communicate issues to management through project management tracking and issue briefings.
  • This role holds significant visibility with both internal and external stakeholders.
  • Exhibit a high level of effective verbal and written communication skills, demonstrating the ability to negotiate, influence, and resolve conflicts.
  • Prior experience in regulatory affairs within the medical device, food, dietary supplement, or pharmaceutical sectors is highly preferred, though not mandatory.
  • Work collaboratively, decisively, and collegially with internal clients (scientists, marketing, quality assurance, product development, affiliates) to address challenges and convey regulatory requirements.
  • Manage and monitor broad and strategic projects effectively.
  • Deliver clear and concise written communications, including briefings and issue analyses.
  • Show a proven ability to work efficiently within a team environment.
  • Accountable for tracking and ensuring the timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities.
  • Responsible for effectively communicating regulatory requirements to project teams and internal stakeholders.


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