Title: Senior Regulatory Affairs Specialist
Location: Saint Paul, MN
Duration: 12 month
Description:
Experience: Must have 3-5 years of experiences in Medical Device Regulatory Affairs
Skills:
- Have working knowledge in EU MDR
- Have working knowledge in Regulatory Change Assessment in
- Have working knowledge in US and EU medical device submissions
- Have experience supporting internal and external inspections
- Work cross-functionally and in a matrixed environment
- Have experience with continuous improvement activities
Education: BA Degree Required
Duties:
- Working with multiple business units to develop, update, and improve regulatory affair processes. 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 the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.
- Identify opportunity for regulatory affair processes and drive changes to completion.
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.