Role : Regulatory Affairs Associate(Medical Devices)

Location : Abbott Park, IL - 60064

Duration : 12 Months

The Regulatory Affairs Specialist ensures regulatory compliance and supports efficient business processes. This role evaluates product and software changes, assists in product registrations, and provides regulatory guidance throughout the product lifecycle.

Responsibilities:

• Provide input for product lifecycle planning and regional regulatory strategies.
• Evaluate software, hardware, and manufacturing changes for regulatory compliance.
• Prepare and review regulatory submissions and documentation.
• Ensure compliance with post marketing approval requirements.
• Manage change controls and determine submission needs.
• Organize tasks, set priorities, and deliver project milestones on time.
• Participate in risk-benefit analyses and team meetings.
• Cultivate cross-functional support networks to achieve objectives.

Qualifications:

• Bachelor’s degree in science, engineering, or a medical field (or equivalent experience).
• 2–3 years in a regulated industry or related field (e.g., software quality assurance, medical technology).
• Knowledge of regulatory guidelines (e.g., GxPs, FDA regulations).
• knowledge of FDA PMA guidance documents and CFR regulations
• Strong communication, analytical, and project management skills.
• Attention to detail, ethical standards, and familiarity with regulatory systems.

Preferred:

• Certification (e.g., RAC or ASCP).
• Experience with Class III medical devices or software-driven clinical analyzers.