Project Manager (Digital Diagnostics)
DxD Hub is seeking an experienced Project Manager to oversee the development and regulatory approval process for software medical devices in collaboration with external partners. The ideal candidate will possess a strong background in project management, regulatory compliance, and a proven track record in successfully managing new product development in the healthcare industry.
Job 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.
- Documentation:
Oversee the creation and maintenance of project documentation, including regulatory submissions and compliance records.
- Continuous Improvement:
Drive process improvements and best practices in project management methodologies.
Job 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.
- Proficiency in project management tools and software (e.g., Jira, Microsoft Project).
- Ability to prioritize and manage multiple projects simultaneously while maintaining attention to detail.
- Certification in Project Management (e.g., PMP) is a plus.