Regulatory Affairs Manager

2 weeks ago


St Paul, United States Intellectt Inc Full time

Role: Regulatory Affairs Manager

Location: St. Paul, MN - 55117

Duration: 6+ Months

Shift Timings: 8 AM to 5 PM


Key Responsibilities:

Leadership & Regulatory Expertise:

  • Lead and manage regulatory submissions for Class III medical devices (IDE, PMA, CE Mark, and clinical trial applications).
  • Develop and execute regulatory strategies to ensure timely approvals in global markets (FDA, EU MDR, and international pathways).

Compliance Management:

  • Monitor and ensure compliance with FDA, QSR, ISO, EN standards, and EU MDR requirements.
  • Review and approve engineering studies, manufacturing changes, and validation protocols for Class III devices.


Must-Have Requirements:

Education: Bachelor’s degree (preferably in science, engineering, or medical disciplines). Advanced degree preferred.

Experience: Minimum 7+ years in medical device regulatory affairs, with 5+ years focused on Class III submissions (FDA and EU MDR).

Skills:

  • Strong knowledge of global regulatory pathways, including FDA guidance and EU MDR.
  • Proven success with regulatory submissions and approvals for Class III devices.
  • Experience with change management, QSR, and compliance reviews.

Preferred Skills:

  • Working knowledge of regulatory requirements for global markets (e.g., Japan, Canada).
  • Strong communication, problem-solving, and organizational skills.
  • Ability to manage multiple priorities and drive results.


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