Title: Regulatory Affairs Associate (Junior Level)
Location: Lake Forest, IL
Duration: 3 Months with possibility for extension and Full-Time Conversion
Job Summary
We are seeking a detail-oriented and highly organized Regulatory Affairs Associate (Junior Level) to support regulatory submissions and ensure compliance with applicable regulations for medical devices. This role involves monitoring evolving global regulatory requirements and effectively communicating them to cross-functional teams. The ideal candidate will possess strong analytical skills, a keen eye for detail, and the ability to manage multiple projects efficiently.
Key Responsibilities
- Manage regulatory submissions to ensure timely approval of medical devices.
- Monitor and interpret changes in global regulatory requirements and communicate them to project development and continuous improvement teams.
- Ensure client products and procedures comply with applicable regulatory agency requirements and guidelines.
- Support the execution of External Regulations, Standards, and Guidance Documents by tracking and monitoring ePAS packages from draft to final closure.
- Prepare and present process-related metrics for Executive Management Review (EMR).
- Conduct final signature approvals for ePAS packages (e.g., FSG Approval).
- Perform data review, analysis, and verification to ensure regulatory compliance.
Required Skills & Qualifications
- Strong analytical and problem-solving abilities.
- Proficiency in Microsoft Excel, Word, PowerPoint, SharePoint, and Teams.
- Excellent verbal and written communication skills, with the ability to engage with diverse audiences and personnel.
- Experience in writing and editing technical documentation.
- Ability to collaborate with professionals from various disciplines and cultural backgrounds.
- Strong attention to detail with exceptional organizational and project management skills.
- Ability to manage and track multiple tasks while developing realistic action plans and prioritizing work activities.
Experience Required
- 1+ years in the medical device industry or a similarly regulated field
Education
- Bachelor's degree in Engineering or a Scientific discipline
Preferred Skills & Experience
- Additional experience in regulatory affairs or quality assurance within a regulated industry.
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.
