Software Medical Device Project Manager - Regulatory Lead

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. 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.