About the role
Project Manager overseeing development and regulatory approval of software medical devices.
ResearchOnsiteDiagnostics Development Hub
Key Responsibilities
- Project Leadership: Lead cross-functional teams in the development and execution of software medical device projects from conception to regulatory approval and market launch.
- Collaboration: Work closely with external collaborators, startups, and industry partners to align project goals, timelines, and regulatory strategies.
- Regulatory Compliance: Ensure adherence to relevant regulations and standards (e.g., FDA, ISO) throughout the development lifecycle.
- Risk Management: Identify and mitigate project risks, ensuring compliance with quality and safety standards.
- Budget and Timeline Management: Develop and maintain project schedules, budgets, and resource allocation plans.
- Stakeholder Communication: Facilitate effective communication between internal teams, external partners, and regulatory authorities.
Requirements
- Bachelor's degree in engineering, Computer Science, or related field. Advanced degree preferred.
- 2+ years of experience in project management within the medical device or healthcare industry.
- Proven track record in managing software medical device development projects from inception to regulatory approval.
- Strong understanding of the software development lifecycle (SDLC) and methodologies (Agile, Waterfall, etc.) in a regulated environment.
- Familiarity with regulatory requirements and standards in the healthcare industry, including IEC 62304 for medical device software lifecycle processes.
- Excellent communication and interpersonal skills to effectively collaborate with diverse stakeholders.