Principal Regulatory Affairs Specialist

Medtronic

Principal Regulatory Affairs Specialist focusing on product compliance and regulatory submissions for Medtronic's Wound Management devices. Collaborate with various teams to ensure regulatory standards are met.

Posted 5/21/2026full-timeBoston • Colorado, Connecticut, Massachusetts, Minnesota • 🇺🇸 United StatesSeniorLead💰 $120,000 - $180,000 per yearWebsite

About the role

Key responsibilities & impact

Provide regulatory affairs domain expertise and influence at all levels in support of the Wound Management device portfolio
Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications
Prepare Pre-Sub and 510(k) submissions and technical documents to support CE mark and other international submissions
Participate in negotiations and interactions with regulatory authorities during the development and review process
Provide business and product information to the international regulatory affairs team
Support international product registrations as needed
Manage multiple projects and prioritize tasks
Collaborate with engineering, quality, clinical, marketing, and other functions

Requirements

What you’ll need

Bachelor’s degree required
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience
Experience successfully achieving FDA clearance through a 510(k) submission
Experience interacting directly with the FDA
Experience managing or contributing to multiple regulatory submissions
Familiarity with medical device regulatory lifecycle management
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.

Benefits

Comp & perks

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 (available to Vice Presidents and above)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory affairs510(k) submissionPre-Sub submissiontechnical document preparationinternational product registrationFDA clearancemedical device regulatory lifecycle management

Soft Skills

strategic inputtechnical guidanceproject managementcollaborationprioritization

Certifications

Bachelor's degreeadvanced degree