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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, focusing on compliance with regulatory standards such as ISO 13485 and 21 CFR 820. Proven ability to lead cross-functional teams, manage budgets, and drive product development in alignment with organizational goals.
Highest-signal resume keywords
Program ManagementRegulatory ComplianceRisk ManagementPMP CertificationAgile Methodologies
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 PlanningBudget ManagementDesign ControlsDigital Health DevelopmentProject Management Tools
Soft Skills
LeadershipProblem-SolvingCommunicationOrganizational Skills
Tools & Technologies
MS OfficeSmartsheet
Certifications & Qualifications
PMP CertificationAgile Training/Certification
Industry Keywords
Medical DeviceBiomedicalLife SciencesFDA 510(K)EU MDRISO 1348521 CFR 820Digital HealthInteroperability StandardsAI Technologies
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Organize and execute a portfolio of programs supporting the product development pipeline
- Lead cross-functional teams from program initiation through commercialization
- Define program scope, objectives, and deliverables with stakeholders
- Develop program plans, schedules, and budgets
- Monitor progress, track milestones, and adjust plans
- Identify risks and implement mitigation strategies
- Manage program resources, personnel, and budgets
- Communicate program status, updates, risks, challenges, 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
- Balance multiple competing priorities across projects
- Work in a matrix management organization with responsibility for project success without direct authority over cross-functional team members
- Ensure compliance with digital health and software as a medical device standards, including quality management systems, software lifecycle requirements, product safety and reliability, labeling and instructions for use, and US and international design control regulations
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
- Agile Training/Certification
- Experience with project management tools, including MS Office and Smartsheet
- 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 oriented
- Experience with budgeting and financial tracking
- 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 eligibility through the Health Investment Plan (HIP) PPO medical plan
- Excellent retirement savings plan with high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit for earning a bachelor’s degree
- Abbott employee health and wellness benefits
- Diversity and inclusion workplace recognition
