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.