We are 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.
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.
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.