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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, with a strong focus on U.S. and EU regulations, including the EU MDR. Proven ability to lead high-performing teams and collaborate effectively with cross-functional stakeholders to ensure compliance and successful product submissions.
Highest-signal resume keywords
Regulatory Affairs ExperienceU.S. And EU Regulatory ComplianceTeam Leadership And DevelopmentFDA Interaction And Submission PreparationMedical Device Regulations Knowledge
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 Strategy DevelopmentSubmission Activities ExecutionDocument Package CoordinationContingency Planning GuidanceRegulatory Review ManagementQuality And Compliance OversightRisk Classification Standards KnowledgeInternal Audits And InspectionsLabeling And Marketing Protocol RecommendationsTracking And Control Systems Improvement
Soft Skills
Problem SolvingTime ManagementEffective CommunicationTeam CollaborationTalent Development
Industry Keywords
Lung Health ProductsGynecologic ProductsMedical Device RegulationsEU MDRRegulatory Agencies InteractionCross-Functional CollaborationHigh-Performance Management CultureEmployee EngagementDynamic Team EnvironmentsRegulatory Submission Goals
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 and resolve complex problems
- Develop regulatory strategies for existing, new, and modified medical devices
- Collaborate with business partners, 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
- Oversee regulatory reviews of advertising and promotional materials
- Sponsor and monitor a high-performance management culture
- Coach, provide feedback, evaluate, and develop team members
- Cultivate a safe, inclusive, and engaging work environment
- Report or present progress regarding product submission goals to senior management
- 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
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment
- Five or more years of medical device regulatory affairs experience 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
- Experience interacting with the FDA and/or other regulatory agencies, including Q-Submission preparation and meetings, submission issue meetings, and other interactions
- 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 the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
Benefits
Comp & perks- Competitive flexible benefits package
- Health insurance
- Dental insurance
- 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
- Short-term incentive through the Medtronic Incentive Plan (MIP)