QA/RA Project Manager
DeepHealth
Senior Program Manager, SaMD
ŌURA
full-time
Posted on:
Origin: • 🇺🇸 United States • New York
Visit company websiteSalary
💰 $139,000 - $203,000 per year
Job Level
Senior
About the role
- Lead cross-functional collaboration to ensure SaMD software is developed, tested, documented, and delivered per requirements
- Define project scope, goals, and deliverables with stakeholders
- Develop project plans with timelines, milestones, budgets
- Coordinate cross-functional teams (TPMs, QA, regulatory, legal, etc.)
- Prepare and submit regulatory documents (510(k), PMA, CE Mark)
- Monitor progress, manage risks
- Communicate with stakeholders; manage relationships with external partners (CROs)
- Manage project budgets; forecast expenditures
- Oversee lifecycle of Software as a Medical Device in alignment with design controls and regulatory
- Foster culture of continuous improvement and high performance
Requirements
- Degree in Biomedical/Mechanical Engineering or related technical/scientific discipline
- 7+ years of experience in project/program management
- Experience with Quality Management Systems
- Experience with medical device regulations and standards
- Experience with risk management
- Experience with medical device software development (IEC 62304)
- Excellent leadership, interpersonal, collaboration, and communication skills
- Ability to understand and articulate the need for diligence in ensuring regulatory and standards compliance
- Strong organizational, prioritization, and execution skills
- Detail-oriented
