Role: Regulatory Affairs Associate

Location: Abbott Park, IL

Duration: 12 Months

Summary:

The Regulatory Affairs Specialist supports regulatory compliance and product registration processes. This role evaluates product and software changes, assists with documentation for global submissions, and ensures adherence to regulatory requirements throughout the product lifecycle.

Responsibilities:

• Provide regulatory input during product development and changes.
• Evaluate and document software, hardware, and manufacturing updates for compliance.
• Assist in preparing and submitting regulatory documents.
• Ensure compliance with postmarketing requirements.
• Participate in risk-benefit analyses and regulatory strategy updates.
• Collaborate with cross-functional teams and support project milestones.

Qualifications:

• Bachelor's degree in science, engineering, or related fields (or equivalent experience).
• 2+ years in a regulated industry (e.g., medical devices, software validation, quality assurance).
• Knowledge of GxP standards and regulatory guidelines is a plus.
• Strong communication, project management, and analytical skills.
• Certification (e.g., RAC, ASCP) is preferred but not required