Regulatory Affair Specialist - Onsite

Medtronic • Minneapolis, MN

1d • $74,400 - $111,600 • Onsite

About The Position

The Regulatory Affairs Specialist supports regulatory strategy, submissions, approvals, and compliance activities for medical devices marketed globally. This role partners with cross-functional teams and international regulatory stakeholders to facilitate product registrations, support product changes, and maintain compliance with applicable regulatory requirements.

Requirements

• Bachelor's degree in a scientific discipline and 2+ years of experience in regulatory affairs, quality, clinical, or medical device-related roles.
• Experience supporting medical devices regulated under FDA requirements, including Class II and/or Class III products.
• Experience preparing or supporting regulatory submissions, including 510(k), Premarket Approval (PMA), European Union Medical Device Regulation (EU MDR), or international regulatory filings.
• Knowledge of FDA regulations, EU MDR requirements, ISO 13485, and ISO 14971 standards.
• Proficiency with Microsoft Office applications.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
• Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

• 2+ years of regulatory affairs experience within the medical device industry.
• Advanced degree in engineering, biological sciences, physical sciences, or health sciences.
• Experience supporting global product registrations and regulatory approvals across multiple regions.
• Experience working in regulated biotechnology or medical device manufacturing environments.
• Experience interacting with regulatory agencies and supporting agency responses.

Responsibilities

• Prepare and support regulatory submissions for the United States, European Union, Canada, and other global markets.
• Collaborate with engineering, quality, clinical, and manufacturing teams to assess regulatory requirements for product changes and new product introductions.
• Develop regulatory documentation to support product registrations, renewals, annual reports, and change notifications.
• Review product labeling, technical documentation, and design changes for regulatory impact and compliance.
• Support interactions with regulatory authorities and respond to regulatory inquiries under the manager's guidance.
• Partner with global regulatory teams to obtain market approvals and maintain product registrations.
• Support regulatory compliance activities, including manufacturing site registrations, audits, vigilance reporting, and recall-related activities.
• Provide regulatory guidance to product development teams throughout the product lifecycle.

Benefits

• 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 (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal