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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive program management expertise within the medical device and life sciences industry, with a strong focus on compliance with ISO 13485 and 21 CFR 820 regulations. Proven ability to lead cross-functional teams, manage budgets, and drive product development in digital health while ensuring alignment with organizational goals.
Highest-signal resume keywords
End-To-End Program ManagementDesign Controls CompliancePMP CertificationDigital Health Product DevelopmentRisk Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Program Scope DefinitionBudget ManagementProject Management MethodologiesRegulatory ComplianceChange ManagementStrategic PlanningFinancial TrackingProcess OptimizationInteroperability StandardsAI Technologies Application
Soft Skills
LeadershipProblem-SolvingCommunicationInfluencingOrganizational Skills
Tools & Technologies
MS OfficeSmartsheets
Certifications & Qualifications
PMP CertificationAgile Training/Certification
Industry Keywords
Medical DeviceBiomedicalLife SciencesDigital HealthFDA 510(K)EU MDRISO 1348521 CFR 820Quality Management SystemsSoftware Lifecycle Requirements
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Organize and execute a portfolio of programs supporting the product development pipeline
- Define program scope, objectives, and deliverables with stakeholders
- Develop detailed program plans, schedules, and budgets
- Lead cross-functional teams from program initiation through commercialization
- Monitor progress, track milestones, and adjust plans as needed
- Identify risks and implement mitigation strategies
- Manage program resources, personnel, and budgets
- Communicate program status, updates, risks, challenges, mitigations, and proposed resolutions to stakeholders and senior leadership
- Ensure alignment with organizational goals, quality standards, and best practices
- Facilitate meetings, maintain documentation, and ensure program governance
- Drive continuous improvement through lessons learned and process optimization
- Apply project management methodologies and best practices
- Work in a matrix management organization with primary responsibility for project success
- Ensure compliance with standards and quality expectations for digital health and software as a medical device, including quality management systems, software lifecycle requirements, product safety and reliability, labeling and instructions for use, and US and international design control obligations
- Travel 15% of the time
Requirements
What you’ll need- Bachelor’s degree in relevant field (e.g., engineering, data science, software)
- 12+ years of end-to-end program management experience within a medical device/biomedical/life sciences industry with a global regulatory context
- Demonstrated experience with Design Controls processes compliant with ISO 13485 standards and 21 CFR 820 regulations
- Working knowledge of FDA 510(K) and/or EU MDR regulatory requirements
- Demonstrated experience in Digital Health product development processes
- Demonstrated success in risk management, change management, and strategic planning
- PMP Certification and Agile Training/Certification
- Experience with project management tools (MS Office, Smartsheets)
- Proven ability to manage multiple projects simultaneously
- Strong organizational, leadership, and problem-solving skills
- Strong verbal and written communication and presentation skills
- Ability to influence and persuade while remaining results orientated
- Experience with budgeting and financial tracking
- Ability to prioritize and balance multiple competing priorities
- Preferred: MBA or other related advanced degree
- Preferred: Familiarity with application of AI technologies in a clinical setting
- Preferred: Experience with interoperability standards (FHIR, HL7, SMART on FHIR)
Benefits
Comp & perks- Career development with an international company
- Free medical coverage in the Health Investment Plan (HIP) PPO medical plan for qualifying employees
- Excellent retirement savings plan with high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit
- Diverse career opportunities
- Health and wellness benefits