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Tandem Diabetes CareCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in post-market surveillance for medical devices, including field actions, complaint handling, and regulatory reporting. Proven leadership in managing cross-functional teams and driving compliance with regulatory requirements while enhancing process performance.
Highest-signal resume keywords
Post-Market Surveillance ManagementRegulatory ReportingField Action LeadershipPeople ManagementProject Management
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Provide leadership and oversight for post-market surveillance activities supporting the safety, performance, quality, and regulatory compliance of medical devices
- Manage Global Post-Market Surveillance personnel, primarily the Field Action Specialist group
- Establish priorities, allocate work and resources, coach and develop employees, and ensure training and coverage
- Oversee post-market surveillance processes, including field actions, vigilance reporting, complaint analysis, trending, signal detection, post-market data review, and regulatory reporting
- Collaborate with Complaint Management, Regulatory Affairs, Quality, Medical or Clinical Affairs, Product Safety, Engineering, Operations, Commercial, Legal, and other functions
- Develop, review, and present PMS metrics, product issues, vigilance performance, field action status, and process performance to management and governance bodies
- Support evaluation, documentation, escalation, and submission of potentially reportable events
- Support preparation, review, or approval of vigilance, follow-up, supplemental, trend, and regulatory authority reports
- Review post-market data to identify trends, signals, changes in product issues, and support investigation and escalation
- Lead global field actions, including recalls, corrections and removals, Field Safety Corrective Actions, Field Safety Notices, product corrections, safety alerts, and jurisdiction-specific market actions
- Lead cross-functional field action teams from initiation through documented closure
- Maintain awareness of global post-market surveillance requirements and support procedures, training, metrics, process improvement, audits, inspections, resource planning, and management reporting
- Support department planning for headcount, budgeting, training, and systems requirements
- Participate in staff selection, development, performance appraisal, merit recommendations, and promotions
- Ensure staff training and compliance with company policies, Privacy/HIPAA, and legal and regulatory requirements
Requirements
What you’ll need- Bachelor’s degree in engineering, life sciences, nursing, pharmacy, regulatory affairs, quality assurance, business, project management, or a related discipline, or equivalent education and applicable work experience
- Eight years of progressively responsible experience in regulated life sciences
- Five years of experience in post-market surveillance or a closely related function
- Two years of formal people-management, supervisory, or equivalent team-leadership experience
- Experience with electronic quality management, complaint handling, regulatory reporting, or comparable PMS systems
- Proficiency with standard business applications
- Broad working knowledge of medical device post-market surveillance, including field actions, complaint handling and analysis, vigilance and adverse event reporting, trending, signal detection, risk management, and quality system principles
- Demonstrated people-management skills, including prioritization, delegation, coaching, performance management, and employee development
- Experience leading complex cross-functional projects
- Experience supporting regulatory inspections, audits, or regulatory authority interactions
- Demonstrated project management capability
- Strong analytical and problem-solving skills
- Strong written and verbal communication skills, including regulatory, technical, customer-facing, and executive-level communications
- Ability to influence and drive accountable execution across functions and regions without relying solely on direct reporting authority
- Skilled in communicating department or area issues and results and presenting technical information
- Skilled at leading cooperative team efforts and organizing resources to achieve team goals
- Ability to make and prioritize process and resource decisions based on overall team needs
- Must be authorized to work for any employer in the United States
- Successful completion of pre-employment drug test and background check required
- Experience with connected, software-driven, drug-delivery, durable medical equipment, or other complex medical devices preferred
- Direct experience with medical device field actions, recalls, corrections and removals, Field Safety Corrective Actions, international vigilance reporting, complaint trending, or signal detection preferred
- Formal project management training or certification (e.g., PMP) and/or quality or regulatory certification preferred
Benefits
Comp & perks- Medical, dental, and vision benefits available the first day
- Health savings accounts
- Flexible spending accounts
- 11 paid holidays per year
- Minimum of 20 days of paid time off, with accrual starting on day 1
- 401(k) plan with company match
- Employee Stock Purchase Plan
- Bonus and competitive compensation package
- Fully remote work within the United States
- Equipment provided
- Virtual training
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Post-Market SurveillanceComplaint HandlingVigilance ReportingSignal DetectionRisk ManagementQuality System PrinciplesData AnalysisRegulatory ComplianceProcess ImprovementTrend Analysis
Soft Skills
Analytical SkillsProblem-Solving SkillsCommunication SkillsCoaching SkillsTeam Leadership
Tools & Technologies
Electronic Quality Management SystemsBusiness ApplicationsPMS Systems
Certifications & Qualifications
Project Management Certification (e.g., PMP)Quality or Regulatory Certification
Industry Keywords
Medical DevicesField Safety Corrective ActionsAdverse Event ReportingRegulatory InspectionsLife Sciences