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.

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