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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. Proven ability to develop and execute regulatory strategies that align with business objectives while mentoring junior staff and collaborating with cross-functional teams.
Highest-signal resume keywords
Medical Device Regulatory AffairsU.S. Class II And III Regulatory RequirementsEU MDR And ISO StandardsRegulatory 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 SubmissionsEU Technical DocumentationRisk Management PrinciplesAdvertising And Promotional Material ReviewRegulatory Agency InteractionsCAPA ActivitiesRegulatory Training DevelopmentPathway AssessmentClassification And Data RequirementsChange Notifications
Soft Skills
CollaborativeSolution-OrientedMentoringCommunicationStakeholder Engagement
Industry Keywords
Robotics Surgery TechnologiesGlobal Regulatory StrategiesLifecycle ManagementPost-Market ReleaseBusiness Transition ActivitiesRegulatory Impact AssessmentRegulatory Subject Matter ExpertU.S. Work AuthorizationISO 13485ISO 14971
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 across early development, commercialization, lifecycle management, and business transition activities
- Support complex post-market release and sustaining change activities
- Set objectives aligned with broader business and portfolio goals and drive regulatory strategy with limited supervision
- Assess regulatory impact on business decisions
- Communicate with internal stakeholders to provide strategic input, share updates, and support informed decision-making
- Serve as a regulatory subject matter expert and individually contributing leader
- Mentor or provide guidance to junior regulatory professionals or support staff
- Lead and execute global regulatory strategies across the product lifecycle, including early development and business wind-down activities
- Provide regulatory strategy input for early-stage development, including pathway assessment, classification, and data requirements
- Partner with R&D, marketing, clinical, operations, and leadership to integrate regulatory considerations into product and business decisions
- Lead or oversee advertising and promotional material review, providing guidance on claims, risk communication, and compliant promotional approaches
- Lead or oversee preparation of U.S. and EU regulatory submissions and support submissions for global markets
- Recommend and guide changes to labeling, manufacturing, marketing, and clinical activities
- Monitor and interpret global regulatory requirements and changes and communicate risks and opportunities to stakeholders
- Support and lead regulatory agency interactions, audits, inspections, and CAPA activities
- Develop and deliver regulatory training and mentor junior regulatory staff
Requirements
What you’ll need- Bachelor’s degree required
- Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience
- 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
- Extensive experience in medical device regulatory affairs
- Strong hands-on experience with U.S. Class II and III medical devices, including applicable regulatory requirements and consensus standards
- In-depth knowledge of EU MDR, ISO 13485, ISO 14971 risk management principles, and ISO 10993-1
- Proven experience authoring and leading U.S. regulatory submissions (e.g., 510(k), PMA, IDE) and EU Technical Documentation and change notifications
- Demonstrated expertise in compiling and maintaining EU MDR Technical Documentation
- Experience interacting directly with regulatory authorities in the U.S., EU, and/or other global markets
- Strong experience reviewing and advising on advertising and promotional materials for U.S. and EU markets
- Demonstrated ability to develop and execute regulatory strategies that support business and product objectives
- Collaborative, solution-oriented professional with a strong focus on delivering value to stakeholders and the organization
- U.S. work authorization requirements apply; sponsorship is offered for Principal-level roles and above
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