Regulatory Specialist II - IVDR (EU) Onsite

Abbott; South Portland (ME); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

MetLife Insurance Options

Job summary

Abbott in South Portland, ME seeks a Regulatory Specialist II to manage IVDR-compliant technical writing and regulatory support for diagnostic products. The role develops regulatory strategies for EU and international approvals, supports regional teams with submissions and license amendments, and maintains ongoing marketing authorizations.

Responsibilities include preparing submission documents, organizing files, and training stakeholders while ensuring compliance with ISO, FDA, and other

Qualifications

• Bachelor’s degree in science or engineering field.
• 4+ years in Regulatory Affairs role.
• Strong knowledge of IVDR and EU regulatory requirements.

Responsibilities

• Prepare regulatory files under IVDR requirements.
• Support regulatory submissions and license renewals.
• Develop strategies for EU/international clearances.
• Maintain approvals and track regulatory changes.
• Create internal procedures and training for stakeholders.
• Organize department files and ensure documentation.
• Assist regional teams with submissions and amendments.
• Ensure compliance with ISO, FDA, and other agencies.

Skills

EU regulations

Regulatory writing

Verbal communication

Time management

Independent work

MS Office

Skills-Based Hiring

Education

Bachelor’s degree in science/engineering

4+ years Regulatory Affairs

IVDR knowledge

Job description

Abbott in South Portland, ME seeks a Regulatory Specialist II to manage IVDR-compliant technical writing and regulatory support for diagnostic products. The role develops regulatory strategies for EU and international approvals, supports regional teams with submissions and license amendments, and maintains ongoing marketing authorizations.

Responsibilities include preparing submission documents, organizing files, and training stakeholders while ensuring compliance with ISO, FDA, and other