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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory affairs for medical devices, including U.S. and EU regulations, with a strong focus on leading teams and developing regulatory strategies for product submissions. Proven ability to collaborate across functions and manage regulatory compliance throughout the product lifecycle.
Highest-signal resume keywords
Regulatory Affairs LeadershipMedical Device Regulatory ExperienceU.S. And EU Regulatory KnowledgeTeam Performance ManagementCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Submission ActivitiesRegulatory ComplianceQ-Submission PreparationRegulatory Strategy DevelopmentDocument Package CoordinationRegulatory ReviewsContingency Planning GuidanceLabeling Changes RecommendationsTracking And Control Systems ImprovementPerformance Evaluations
Soft Skills
Hands-On LeadershipTalent DevelopmentEffective CommunicationProblem-SolvingTime Management
Industry Keywords
Surgical Operating UnitFDA InteractionEU MDRMedical Device StandardsCross-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
- Achieve results through hands-on leadership and delegation to individual contributors
- Collaborate with business partners to develop regulatory strategies supporting business goals 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
- 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
- Lead interactions with regulatory agencies and support regulatory reviews
- Provide guidance on regulatory requirements for contingency planning and ensure 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
- Provide career coaching, feedback, performance evaluations, and development support
- Cultivate a safe, inclusive, and engaging work environment
- Report periodically to senior management on 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
- Experience serving as a Regulatory Affairs lead for new product development projects
- 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, and the Employee Stock Purchase Plan
- Short-term incentive called the Medtronic Incentive Plan (MIP)