Global Regulatory Affairs Specialist, Medical Devices

Abbott; Illinois; On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO

High employer retirement contribution

Tuition reimbursement

FreeU education benefit

Job summary

Abbott Park, IL-based Regulatory Affairs Specialist role within the Transfusion Medicine Business. This position focuses on regulatory strategy, submissions, and compliance for instruments and software, contributing to market entries and on-market support.

You will collaborate with Regulatory and cross-functional teams to prepare registrations for US and international markets, support audits, and guide lifecycle planning while ensuring timely approvals.

Qualifications

• Bachelor's degree in science or related field.
• 2–3 years of experience in a regulated industry (medical devices/pharma) preferred.
• Regulatory affairs experience or related quality assurance/ R&D exposure is valued.

Responsibilities

• Participate as the regulatory functional product team member for Transfusion Medicine.
• Support regulatory activities required for market entry and on-market support of instrument hardware and software.
• Work with Regulatory and cross-functional teams to improve efficiency of regulatory deliverables.
• Determine regulatory strategies for US and international markets for new products in development.
• Survey country-specific regulatory experts to obtain feedback and compile information for core teams.
• Assist in SOP development and provide regulatory input to product lifecycle planning.
• Monitor and communicate submission timelines and regulatory review status to the core team.

Skills

Regulatory affairs

Regulatory documentation

Cross-functional teamwork

Education

Bachelor's degree in science

Job description

Abbott Park, IL-based Regulatory Affairs Specialist role within the Transfusion Medicine Business. This position focuses on regulatory strategy, submissions, and compliance for instruments and software, contributing to market entries and on-market support.

You will collaborate with Regulatory and cross-functional teams to prepare registrations for US and international markets, support audits, and guide lifecycle planning while ensuring timely approvals.