Project Manager, Digital Diagnostics

A*STAR - Agency for Science, Technology and Research; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

A*STAR - Agency for Science, Technology and Research in Singapore is seeking an experienced Project Manager for Digital Diagnostics. The successful candidate will lead cross-functional teams and manage software medical device projects from conception to regulatory approval. This role requires a Bachelor's degree, 2+ years of experience in healthcare project management, and proficiency in tools like Jira and Microsoft Project. Excellent communication skills and a strong understanding of regulatory compliance are essential.

Qualifications

• 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.
• Excellent communication and interpersonal skills to effectively collaborate with diverse stakeholders.

Responsibilities

• Lead cross‑functional teams in the development and execution of software medical device projects.
• Work closely with external collaborators to align project goals and regulatory strategies.
• Ensure adherence to relevant regulations and standards throughout the development lifecycle.
• Identify and mitigate project risks, ensuring compliance with quality and safety standards.
• Develop and maintain project schedules, budgets, and resource allocation plans.

Skills

Project management

Regulatory compliance

Software development lifecycle

Communication skills

Agile methodologies

Risk management

Education

Bachelor's degree in engineering or Computer Science

Advanced degree preferred

Certification in Project Management (e.g. PMP)

Tools

Jira

Microsoft Project

Job description

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.