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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in medical device regulatory affairs, including U.S. Class II and III devices, EU MDR, and ISO standards. Capable of developing and executing regulatory strategies while mentoring junior staff and collaborating with cross-functional teams.
Highest-signal resume keywords
Medical Device Regulatory AffairsU.S. Class II And III DevicesEU MDR Technical DocumentationRegulatory Submissions (510(k), PMA, IDE)Regulatory Strategy Development
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 LeadershipPathway AssessmentClassification And Data RequirementsAdvertising And Promotional Material ReviewRisk CommunicationRegulatory Agency InteractionsCAPA ActivitiesRegulatory Training DevelopmentEU Technical DocumentationChange Notifications
Soft Skills
CollaborationMentoringCommunication
Industry Keywords
ISO 13485ISO 14971ISO 10993-1Global Regulatory RequirementsLifecycle ManagementBusiness Wind-Down ActivitiesRegulatory Authority InteractionRisk Management Principles
About the role
Key responsibilities & impact- Provide regulatory leadership and strategic direction for the consumable product portfolio within Robotics Surgery Technologies
- Collaborate with cross-functional partners to develop, plan, and execute global regulatory strategies
- Lead regulatory strategies across early development, commercialization, lifecycle management, and business wind-down activities
- Provide regulatory input on pathway assessment, classification, and data requirements for early-stage development
- Partner with R&D, marketing, clinical, operations, and leadership on product and business decisions
- Lead or oversee U.S. and EU regulatory submissions and support submissions for global markets
- Lead advertising and promotional material reviews, including claims, risk communication, and compliant promotional approaches
- Recommend and guide changes to labeling, manufacturing, marketing, and clinical activities
- Monitor and interpret global regulatory requirements and communicate risks and opportunities
- Support and lead regulatory agency interactions, audits, inspections, and CAPA activities
- Develop and deliver regulatory training
- Mentor junior regulatory staff and provide guidance to support staff as needed
Requirements
What you’ll need- Bachelor’s degree required
- Minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience
- Extensive experience in medical device regulatory affairs
- Strong hands-on experience with U.S. Class II and III medical devices
- Knowledge of applicable regulatory requirements and consensus standards
- In-depth knowledge of EU MDR, ISO 13485, ISO 14971 risk management principles, and ISO 10993-1
- Experience authoring and leading U.S. regulatory submissions, including 510(k), PMA, and IDE
- Experience with EU Technical Documentation and change notifications
- Expertise compiling and maintaining EU MDR Technical Documentation
- Experience interacting directly with regulatory authorities in the U.S., EU, and/or other global markets
- Experience reviewing and advising on advertising and promotional materials for U.S. and EU markets
- Ability to develop and execute regulatory strategies supporting business and product objectives
- 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 salary
- 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
- Paid sick time for temporary employees as required by applicable state law
- Reasonable accommodations for qualified individuals with disabilities