Project Manager, Digital Diagnostics

A*STAR RESEARCH ENTITIES; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

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. Lead cross-functional teams through conception to regulatory approval and market launch.

Work closely with startups and industry partners to align goals and regulatory strategies, ensuring compliance with FDA/ISO and managing risks, budgets, and timelines.

Qualifications

• Bachelor's degree in engineering, computer science or related field; advanced degree preferred.
• 2+ years of project management experience in medical devices or healthcare.
• Proven track record managing software medical device development from concept to regulatory approval.
• Strong understanding of software development lifecycle (SDLC) in regulated environments.
• Familiarity with IEC 62304 and related healthcare regulatory standards.

Responsibilities

• Lead cross-functional teams from conception to regulatory approval and market launch.
• Collaborate with external partners, startups and industry to align goals and regulatory strategies.
• Ensure adherence to regulatory requirements and standards (FDA/ISO) throughout development.
• Identify and mitigate project risks, ensuring quality and safety compliance.
• Develop and maintain project schedules, budgets and resource plans.
• Facilitate stakeholder communication between internal teams, partners and regulators.
• Oversee creation and maintenance of regulatory submissions and compliance records.
• Drive process improvements and best practices in project management.

Skills

Project management

Regulatory compliance

SDLC knowledge

Jira

PMP certification

Education

Bachelor's degree in engineering, CS or related

Tools

Jira

Microsoft Project

Job description

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.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.