Principal Regulatory Affairs Specialist

Medtronic

Principal Regulatory Affairs Specialist at Medtronic, focusing on Wound Management products. Ensuring compliance with US and EU regulations and supporting international submissions.

Posted 7/22/2026full-timeNorth Haven • Colorado, Connecticut, Massachusetts, Minnesota • 🇺🇸 United StatesSeniorLead💰 $120,000 - $180,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive regulatory affairs expertise in the Wound Management device portfolio, with a strong focus on FDA 510(k) submissions and international regulatory compliance. Capable of managing multiple projects while collaborating effectively across engineering, quality, and marketing functions.

Highest-signal resume keywords

Regulatory Affairs ExpertiseFDA 510(k) Submission ExperienceInternational Regulatory ComplianceProject ManagementMedical Device Regulatory Lifecycle Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsTechnical Document PreparationPre-Sub PreparationRegulatory KnowledgeCompliance DocumentationAudit ParticipationRegulatory Procedures CreationProduct Registration SupportNegotiation with Regulatory AuthoritiesPromotional Material Review

Soft Skills

CollaborationCommunicationStrategic InputInfluencePrioritization

Industry Keywords

Wound ManagementMedical DeviceDomestic RegulationsInternational RegulationsRegulatory GuidelinesCE MarkRegulatory Affairs DocumentationQuality StandardsClinical InteractionEngineering Collaboration

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, considering both domestic and international regulations
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 to enable development and strategies and requirements and communicate that information to the business team
Support international product registrations as needed
Manage multiple projects and prioritize tasks on day by day basis to meet project schedules
Collaborate with engineering, quality, clinical, marketing, and other functions to fulfill responsibilities
Review promotional and advertising material
Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
Participate in internal and external audits
Maintain regulatory affairs documentation to support compliance with applicable regulatory requirements
Perform other duties as assigned or required.

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