Job Summary

• Responsible for developing regulatory strategies, preparing U.S. regulatory submissions, and obtaining and maintaining approval for products and therapies to markets worldwide.
• Work on 510(k) submissions for US Class II medical devices and EU MDD/MDR technical documentation, supporting reviews of Clinical Evaluation Reports, Risk Management, and Design Verification/Validation.
• The position works as a hybrid model and will be onsite at the Mounds View, MN location 4 days per week, with a comprehensive benefits package including health, dental, vision, and retirement plans.

Matching Summary

Salary

$110,200 to $138,000 per year; Not specified; Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, Simple Steps (global well-being program), Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement, Capital Accumulation Plan

Skills & Requirements

Key Requirements

• Master's degree and 3 years experience OR Bachelor's degree and 5 years experience
• 3 years experience with 510(k) submissions
• 3 years experience authoring EU MDD/MDR documentation
• 3 years experience reviewing DHF or EU deliverables
• 3 years experience supporting product life cycle
• 3 years experience with QSR, EU MDD/MDR, and ISO 13485
• 3 years experience with ISO 10993-1, IEC 60601, IEC 62304
• 3 years experience supporting OUS regulatory requirements

Work Rights