Regulatory Affair Specialist

Medtronic is hiring a Regulatory Affairs Specialist to support regulatory strategy, submissions, approvals, and compliance for medical devices marketed globally. The role partners with cross-functional and international teams to facilitate product registrations, assess product changes, and maintain regulatory compliance throughout the product lifecycle.

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

Preferred

• 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
• 2+ years of regulatory affairs experience within the medical device industry.
• Regulatory Affairs
• Medical Device Industry
• Biological Sciences
• Physical Sciences
• Health Sciences
• Global Product Registration
• Regulatory Approvals
• Regulated Biotechnology
• Medical Device Manufacturing
• Agency Response Support
• Regulatory Agency Communication

Benefits

• Short-term incentive through the Medtronic Incentive Plan (MIP)
• For regular employees working 20+ hours per week: Health, Dental and vision insurance
• For regular employees working 20+ hours per week: Health Savings Account
• For regular employees working 20+ hours per week: Healthcare Flexible Spending Account
• For regular employees working 20+ hours per week: Life insurance
• For regular employees working 20+ hours per week: Long-term disability leave
• For regular employees working 20+ hours per week: Dependent daycare spending account
• For regular employees working 20+ hours per week: Tuition assistance/reimbursement
• For regular employees working 20+ hours per week: Simple Steps global well-being program
• For all regular employees: Incentive plans
• For all regular employees: 401(k) plan plus employer contribution and match
• For all regular employees: Short-term disability
• For all regular employees: Paid time off
• For all regular employees: Paid holidays
• For all regular employees: Employee Stock Purchase Plan
• For all regular employees: Employee Assistance Program
• For all regular employees: Non-qualified Retirement Plan Supplement, subject to IRS earning minimums
• For all regular employees: Capital Accumulation Plan, available to Vice Presidents and above, or subject to IRS earning minimums
• Temporary employees: paid sick time, as required under applicable state law
• Temporary employees: Employee Stock Purchase Plan

Company

• Global healthcare technology company
• Minneapolis, Minnesota, USA
• https://www.medtronic.com/
• Founded in 1949
• 10001+ employees

Qualifications

• 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
• Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment
• 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
• Bachelor's degree in a scientific discipline and 2+ years of experience in regulatory affairs, quality, clinical, or medical device-related roles.

Required skills

• 510(k) Submissions, EU Medical Device Regulation (EU MDR), Global Product Registrations, ISO 13485, ISO 14971, Medical Device Regulatory Affairs, Premarket Approval (PMA)

Experience

• 2+ years