Regulatory Affairs Specialist, Medical Devices

Thornton Tomasetti; United States; On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott Park, IL is seeking a Regulatory Affairs Specialist to support Transfusion Medicine regulatory activities. You will participate on the regulatory team and help with market entry and on-market support for instrument hardware and software. The role involves coordinating with global experts and preparing submissions for multiple markets.

The position emphasizes collaboration to improve efficiency, regulatory strategy development, and governance of documentation across product lifecycles.

Qualifications

• Bachelor's degree in science or related field.
• 2-3 years of experience in a regulated industry.
• Regulatory experience preferred; RAC or advanced degree advantageous.

Responsibilities

• Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team.
• Support regulatory activities for product market entry and on-market support of instrument hardware and software.
• Collaborate with Regulatory and cross-functional teams to improve deliverable efficiency.
• Determine regulatory strategies for approval/clearance/registration for US and International markets.
• Coordinate with country-specific regulatory experts for feedback during development.
• Prepare documentation for registration worldwide or oversee such preparation.
• Assist in SOP development and review.
• Provide regulatory input to product lifecycle planning.

Skills

Regulatory experience

FDA submissions experience

Education

Bachelor's degree in science

Master’s degree in regulatory affairs

Regulatory Affairs Certification (RAC)

Advanced degree in a technical or medically related area

Job description

Abbott Park, IL is seeking a Regulatory Affairs Specialist to support Transfusion Medicine regulatory activities. You will participate on the regulatory team and help with market entry and on-market support for instrument hardware and software. The role involves coordinating with global experts and preparing submissions for multiple markets.

The position emphasizes collaboration to improve efficiency, regulatory strategy development, and governance of documentation across product lifecycles.