Global Regulatory Affairs Specialist – Medical Devices

Abbott Laboratories; Illinois; On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Free medical coverage

Retirement plan with high employer con

Tuition reimbursement

Education benefit - FreeU

Job summary

Abbott Park, IL, in the Transfusion Medicine Business, seeks a Regulatory Affairs Specialist to support regulatory activities for instrument hardware and software. You will work with Regulatory and cross-functional teams to ensure compliance for market entry and on-market support.

The role requires a science degree and 2–3 years in a regulated environment; RAC and device experience are a plus. Abbott offers strong benefits and career growth opportunities.

Qualifications

• Bachelor's degree in science (e.g., biology, chemistry, biochemistry, microbiology, immunology, medical technology, pharmacy/pharmacology, nursing, engineering) required.
• 2-3 years of experience in a regulated industry (medical devices or pharmaceuticals) preferred.

Responsibilities

• Participate as the regulatory functional product team member for the Transfusion Medicine regulatory team.
• Prepare documentation for registration worldwide or oversee such preparation and support compliance audits.
• Monitor changing regulations and communicate submission timelines to the product teams.
• Assess regulatory history to determine strategies for US and international approvals.
• Collaborate with country-specific regulatory experts for feedback during development.

Education

Bachelor's degree in science

Job description

Abbott Park, IL, in the Transfusion Medicine Business, seeks a Regulatory Affairs Specialist to support regulatory activities for instrument hardware and software. You will work with Regulatory and cross-functional teams to ensure compliance for market entry and on-market support.

The role requires a science degree and 2–3 years in a regulated environment; RAC and device experience are a plus. Abbott offers strong benefits and career growth opportunities.