Regulatory affairs associate Job at Intellectt Inc, Chicago, IL

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  • Intellectt Inc
  • Chicago, IL

Job Description

Hello

Hope you are doing well.

This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to jahera@intellectt.com or call me at +1(732)-276-1791.

Role: Regulatory Affairs Associate

Location: Abbott Park, IL - 60064

Duration: 12 Months

Responsibilities:

  • Provide regulatory input for product lifecycle planning.
  • Evaluate software, hardware, and manufacturing changes for regulatory filing strategies.
  • Assist in developing and updating regional regulatory strategies.
  • Participate in risk-benefit analysis for regulatory compliance.
  • Prepare and review regulatory submissions to authorities.
  • Ensure compliance with product post-marketing approval requirements.
  • Manage change controls to determine submission requirements.
  • Organize and lead team meetings, set priorities, and meet project milestones .

Experience:

  • 2–3 years in a regulated industry (e.g., medical products, medical device software).
  • Preferred: Experience in software verification/validation, software quality assurance, or as a Medical Technologist familiar with software-driven clinical analyzers.

Key Skills:

  • RAC certification (Regulatory Affairs Professionals Society) or Medical Technologist (ASCP) certification is a plus.

Education:

  • Bachelor’s degree in science (biology, chemistry, pharmacology, etc.), engineering, math, or medical fields is preferred.

Job Tags

Contract work,

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