Regulatory Affairs Manager

Medtronic

. Establish strategies for worldwide product approval and submission activities .

Posted 10/5/2026full-timeUnited StatesSeniorLead💰 $120,800 - $181,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs for medical devices, with a strong focus on U.S. and EU regulations, including the EU MDR. Proven ability to lead high-performing teams and collaborate across functions to ensure compliance and successful product submissions.

Highest-signal resume keywords

Regulatory Affairs ExperienceU.S. And EU Regulatory KnowledgeTeam LeadershipMedical Device Submission ManagementCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentSubmission Activities ExecutionRegulatory Compliance ManagementDocument Package CoordinationQ-Submission PreparationRegulatory Review OversightPerformance ManagementContingency PlanningLabeling Changes RecommendationTracking And Control Systems Improvement

Soft Skills

Talent DevelopmentProblem SolvingEffective CommunicationTime ManagementTeam Engagement

Industry Keywords

Lung Health ProductsGynecologic ProductsFDA InteractionInternational RegulationsMedical Device Risk ClassificationsQuality Assurance CollaborationClinical ProtocolsAdvertising And Promotional Material ReviewEmployee Engagement InitiativesDynamic Team Environments

About the role

Key responsibilities & impact

Establish strategies for worldwide product approval and submission activities
Directly execute submission activities focused on the U.S. and EU
Ensure regulatory compliance for Lung Health and Gynecologic products within the Surgical organization
Oversee day-to-day functions of the Lung Health and Gynecologic Regulatory Affairs team
Become actively involved in daily operations to meet schedules or resolve complex problems
Develop regulatory strategies for existing, new, and modified medical devices
Collaborate across a matrixed organization to ensure global product success
Collaborate with external regulatory authorities and cross-functional stakeholders
Lead interactions with regulatory agencies during strategy development and regulatory reviews
Provide guidance on regulatory requirements for contingency planning and compliance
Partner with quality, engineering, clinical, manufacturing, and commercial teams throughout the product lifecycle
Manage team performance, resource planning, talent development, succession planning, and employee engagement initiatives
Oversee regulatory reviews of advertising and promotional materials
Sponsor and monitor a high-performance management culture
Provide career coaching, feedback, performance evaluations, and development support
Cultivate a safe, inclusive, and engaging work environment
Provide progress reports or presentations to senior management regarding product submission goals
Improve operating mechanisms, communication pathways, and processes
Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections
Lead or compile materials for submissions, license renewals, and annual registrations
Recommend changes to labeling, manufacturing, marketing, and clinical protocols
Monitor and improve tracking and control systems
Keep abreast of regulatory procedures and changes
Direct interaction with regulatory agencies on defined matters

Requirements

What you’ll need

Bachelor’s degree required
Minimum of seven years of relevant experience, or an advanced degree with a minimum of five years of relevant experience
Five or more years of medical device regulatory affairs experience
Degree in engineering or an advanced degree
Proven track record of leading high-performing teams
Ability to recognize and develop key talent
Excellent knowledge of U.S., European, and international regulations, including the EU MDR, as well as standards applicable to products of all risk classifications
Experience interacting with the FDA and/or other regulatory agencies, including Q-Submission preparation and meetings, submission issue meetings, and other interactions
Proven ability to prioritize work, manage time effectively, and meet project deadlines
Ability to work effectively in dynamic, cross-functional team environments
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
Must possess unrestricted U.S. work authorization at the time of hire and for the duration of employment

Benefits

Comp & perks

Competitive salary and flexible Benefits Package
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, or subject to IRS earning minimums)
Temporary employees are eligible for paid sick time, as required under applicable state law
Employee Stock Purchase Plan for temporary employees
Reasonable accommodations for qualified individuals with disabilities