Senior Regulatory Affairs Specialist

Title: Senior Regulatory Affairs Specialist

Location: Lake Forest, Illinois

Duration: 8+ Month

Job Responsibilities Include

• Create and maintain document templates and procedures for In Vitro Diagnostic Regulation (IVDR) performance evaluation documents
• Review and edit quality system documents for accuracy and completeness
• Work with cross-functional teams to ensure that documentation meets all procecural and regulatory requirements.
• Drive cross-functional team activity to complete document approval according to project timelines.
• Ensures that solutions are compliant, thorough, practical and consistent with organizational objectives.
• Quality System Compliance - Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
  
  

Required

EDUCATION AND EXPERIENCE YOU’LL BRING

• Apprenticeship or bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
• At least 5 years work experience in Regulatory Affairs, Quality, or related field experience; Less experience may be appropriate with advanced degree.
• Preferred experience in the Healthcare industry.
  
  

Preferred

• Experience in Design Control, Regulatory documentation and new product development preferred.
• Medical device or in-vitro diagnostics experience strongly desired
• Knowledge of regulations and standards affecting IVDs and Biologics is preferred
• Experience with site audits preferred
• Experience and proficiency with Microsoft applications (Word, Excel, PowerPoint etc.)
• Experience with Technical Writing
  
  

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.