Senior Regulatory Affairs Specialist

About the role

This position will be working with multiple business units to develop, update, and improve regulatory affairs processes in a 100% onsite capacity at Abbott Park, IL for a duration of 7 months.

Responsibilities

• Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Update and develop procedures for regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.
• Identify opportunities for regulatory affairs processes and drive changes to completion.
• Support internal and external inspections.
• Work cross-functionally and in a matrixed environment to advance continuous improvement activities.

Requirements

• 3-5 years of experience in Medical Device Regulatory Affairs.
• Working knowledge of EU MDR.
• Working knowledge of Regulatory Change Assessment.
• Working knowledge of US and EU medical device submissions.
• BA Degree required.

Benefits

• 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)

Benefits are available upon waiting period.