Job Title: Regulatory Specialist II
Location: 65 Gannett Drive, South Portland, ME 04106
Duration: 9 Months
Work Arrangement: 100% Onsite
Position Overview
The Regulatory Affairs Specialist II position is within Abbott’s Infectious Disease business unit. This role is responsible for preparing and maintaining EU Technical Files and supporting international product registrations for in vitro diagnostic (IVD) medical devices. The specialist will provide regulatory guidance throughout the product lifecycle to ensure compliance with applicable EU and international regulations.
Key Responsibilities
- Prepare and author EU Technical Files in accordance with In Vitro Diagnostic Regulation (IVDR) requirements.
- Provide regulatory support for diagnostic product development and commercially released diagnostic products.
- Develop regulatory strategies for products in development and for product modifications to achieve EU and international clearances and approvals.
- Support regional regulatory teams with submissions, license renewals, and license amendments.
- Research, interpret, and communicate scientific and regulatory requirements to develop submission documentation.
- Compile, review, and publish materials required for submissions, renewals, and annual registrations.
- Maintain marketing authorizations, approvals, licenses, and related regulatory documentation.
- Assess product, manufacturing, and labeling changes to determine regulatory reporting requirements and compliance impact.
- Develop and maintain internal regulatory procedures and tools.
- Conduct informational sessions and training for internal stakeholders.
- Organize and maintain both hard copy and electronic regulatory files.
- Support and promote compliance with Abbott’s Quality Management System in alignment with ISO, FDA, and other applicable regulatory standards.
- Demonstrate professional conduct with internal and external business partners in accordance with company policies and practices.
Basic Qualifications
- Bachelor’s Degree in Biology, Chemistry, Biochemistry, Engineering, or a related technical field, or an equivalent combination of education and experience.
- Minimum of 4 years of experience in a Regulatory Affairs role.
- Strong knowledge of IVDR and EU regulatory requirements.
Preferred Qualifications
- At least 1 year of experience in an IVD or medical device manufacturing environment.
Core Competencies
- Solid understanding of EU and international regulatory frameworks.
- Strong written and verbal communication skills.
- Excellent time management skills with the ability to manage multiple projects simultaneously.
Consultants Eligible Benefits Upon Waiting Period
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account (for High Deductible Health Plans)
- Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
- Supplemental Life Insurance
- Short Term Disability (coverage varies by state)
- Long Term Disability
- Critical Illness, Hospital coverage, Accident Insurance
- MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
- 401(k)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
