Senior Regulatory Affairs Leader

2 weeks ago


Denver, Colorado, United States Proclinical Staffing Full time

Senior Regulatory Affairs Leader

We are seeking a Senior Regulatory Affairs Leader to become part of an innovative medical technology organization. This company is at the forefront of developing Software as a Medical Device (SaMD) utilizing advanced AI/ML technologies.

Key Responsibilities:

  • Formulate and implement regulatory strategies for cutting-edge medical technology products while managing a portfolio of 510(k) submissions.
  • Engage collaboratively with Research & Development and Clinical teams to establish validation strategies and design clinical protocols.
  • Prepare and uphold regulatory documentation pertinent to SaMD submissions.
  • Oversee compliance activities with the FDA and other regulatory bodies related to designated responsibilities in a timely manner.

If you possess a robust background in Regulatory Affairs within the Medical Devices field and have experience with SaMD, SaaS, or embedded software solutions, we invite you to explore this opportunity. Join us in our mission to foster innovation and enhance clinical outcomes for patients globally.

Proclinical Staffing is a dedicated recruitment agency that collaborates with top-tier pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. We are devoted to promoting equal employment opportunities for all candidates.



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