Role: Regulatory Affairs Associate

Location: Abbott Park, Illinois

Responsibilities:

• Provide expert regulatory input during the product lifecycle planning stages.
• Evaluate software, hardware, and manufacturing changes to determine appropriate regulatory filing strategies.
• Assist in creating and updating regional regulatory strategies in response to regulatory changes.
• Participate in risk-benefit analyses to ensure regulatory compliance.
• Prepare and review regulatory submissions for authorities and ensure compliance with post-marketing approval requirements.
• Plan and organize non-routine tasks, maintaining work schedules and ensuring on-time delivery of project milestones.
• Establish work priorities and collaborate with extensive internal and external networks to facilitate project completion.
• Use innovative and practical methods to resolve problems, where failure to achieve results could lead to delays or resource misallocation.
• 2 3 years in a regulated industry (e.g., medical products, medical device software).
• Alternatively, 2 years in software verification/validation, software quality assurance, or as a Medical Technologist familiar with software-driven clinical analyzers.
• Experience in regulatory areas with software knowledge is preferred. May also consider experience in quality assurance, R&D/support, scientific affairs, or related areas.
• Bachelor's degree in science (e.g., biology, chemistry, microbiology, immunology, medical technology, pharmacy, and pharmacology), mathematics, engineering, or medical fields preferred.
• RAC (Regulatory Affairs Certification) from the Regulatory Affairs Professionals Society or Medical Technologist certification (ASCP) is a plus.