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About the role
Key responsibilities & impact- Guide teams through regulated product lifecycles, including design and development or change plans, release management and post-market support.
- Own the delivery of a digital product or suite of product development initiatives by creating integrated plans, cross-functional schedules and dependencies.
- Coordinate the resolution of technical challenges and translate tradeoffs to business teams in clear business terms.
- Facilitate operating cadence (cross-functional meetings, design reviews), safeguard documentation and compliance (robust design control traceability and audit-ready design history files), enforce stage-gate criteria and continuous risk reduction.
- Coach and mentor junior staff on SaMD regulations and development strategies.
- Partner with engineering, quality, regulatory, privacy, security and clinical teams to assess risks related to updates, design changes, platform changes or integrations ensuring that appropriate mitigations are defined and implemented.
- Coordinate and advise across digital application efforts for a globally diverse, multi-product connected system.
- Ensure compliance with all relevant standards and quality expectations for digital health and software as a medical device.
Requirements
What you’ll need- 10+ years in program/project management
- 5+ years in regulated digital health or software
- Bachelor’s degree in engineering or science equivalent
- Ability to travel 10% of the time, including internationally
- Strong leadership and communication skills across multiple levels of the organization
- 3+ years of experience directly managing technical staff
- Program/Project Management certifications.
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
program managementproject managementdigital product developmentdesign controlrisk managementcomplianceSaMD regulationstechnical challenge resolutioncross-functional coordinationaudit-ready design history files
Soft Skills
leadershipcommunicationmentoringcoachingorganizational skillsfacilitationcollaborationproblem-solvingadaptabilitystakeholder management
Certifications
Program Management certificationProject Management certification