Enabling better, smarter, safer healthcare to improve lives.
Senior Regulatory Affairs Specialist
Location
Minnesota
Posted
19 days ago
Salary
$124K - $170.5K / year
Job Description
Job Requirements
- Bachelor’s Degree or higher in a science or engineering discipline AND five (5) years of experience in regulatory affairs in the medical device industry OR High School Diploma/GED AND nine (9) years of experience in regulatory affairs in the medical device industry
- Experience working on combination medical devices with an antimicrobial
- Direct experience authoring regulatory submissions/technical documentation
- Direct experience authoring regulatory strategies and regulatory change assessments
- Experience working and providing regulatory support for new product development teams
- Experience developing regulatory strategies and project management
- Skills include regulatory acumen, cross functional project management, stakeholder management, international submission support, Medical Devices, proficient in Office Suite and Regulatory Management Software
Benefits
- Medical, Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
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