Regulatory Affairs Manager

Medtronic

. Establish strategies for worldwide product approval and submission activities .

Posted 10/21/2026full-timeUnited StatesMid-LevelSenior💰 $120,800 - $181,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs for medical devices, including U.S. and EU regulations, with a strong focus on leading teams and managing product submissions. Proven ability to collaborate with cross-functional teams and regulatory agencies to ensure compliance and successful product development.

Highest-signal resume keywords

Regulatory Affairs LeadershipMedical Device Regulatory ComplianceU.S. And EU Regulatory KnowledgeTeam Performance ManagementCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission ActivitiesRegulatory Strategy DevelopmentQ-Submission PreparationRegulatory ReviewsDocument Package CoordinationContingency PlanningPerformance MonitoringLabeling ChangesRisk Classification StandardsInternal Audits

Soft Skills

Problem SolvingTime ManagementCoaching And FeedbackTalent DevelopmentEffective Communication

Industry Keywords

Surgical Operating UnitFDA InteractionEU MDRMedical Device RegulationsCross-Functional 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 products within the Surgical Operating Unit
Lead and delegate responsibilities to Regulatory Affairs individual contributors
Collaborate with business partners to develop regulatory strategies and translate them into team work plans
Serve as regulatory lead for one or more new product development projects
Oversee day-to-day regulatory activities of the Stapling Regulatory Affairs team
Potentially assume direct people management responsibilities as business needs evolve
Resolve complex problems and meet schedules through active involvement in daily operations
Develop regulatory strategies for existing, new, and modified medical devices
Collaborate with 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
Monitor performance expectations, provide coaching and feedback, and conduct performance evaluations
Cultivate a safe, inclusive, and engaging work environment
Report progress 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 5 years of relevant experience, or an advanced degree with a minimum of 3 years of relevant experience
Five or more years of medical device regulatory affairs experience preferred
Experience serving as a Regulatory Affairs lead for new product development projects preferred
Degree in engineering or an advanced degree preferred
Proven track record of leading high-performing teams preferred
Ability to recognize and develop key talent preferred
Excellent knowledge of U.S., European, and international regulations, including the EU MDR, and applicable standards for products of all risk classifications preferred
Experience interacting with the FDA and/or other regulatory agencies, including Q-Submission preparation and meetings, submission issue meetings, and other interactions preferred
Ability to prioritize work, manage time effectively, and meet project deadlines preferred
Ability to work effectively in dynamic, cross-functional team environments preferred
For Baccalaureate degrees earned outside the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
Unrestricted U.S. work authorization at the time of hire and for the duration of employment is required for roles below Principal level

Benefits

Comp & perks

Competitive salary and flexible Benefits Package
Short-term incentive through the Medtronic Incentive Plan (MIP)
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 for eligible employees
Paid sick time for temporary employees as required by applicable state law