Regulated Product Development Program Manager

Jobtailor; Boulder (CO); On-site; USD 120,000 - 170,000; Full time

Job summary

Jobtailor seeks a Program Manager to drive end-to-end product development in regulated environments, coordinating assays, software, and systems development with ISO 13485 and IEC 62304 compliance. You will manage planning, scheduling, resources, and risk across cross-functional teams, ensuring regulatory alignment.

Lead submissions readiness (IDE, 510(k), PMA), partner with external collaborators, and present data-driven recommendations to senior leadership to enable timely decisions.

Qualifications

• 3–5+ years of program management experience in biotech/diagnostics/life sciences.
• Experience in regulated product development environments (IVD/medical devices).
• Background in NGS diagnostics with assay and software components preferred.
• Strong knowledge of ISO 13485 design controls and IEC 62304 lifecycle processes.
• Experience supporting regulatory submissions (IDE, 510(k), PMA) preferred.

Responsibilities

• Drive end-to-end execution of product development programs across assay, software, and systems.
• Coordinate regulatory product development activities and ensure traceability of requirements.
• Lead cross-functional alignment among R&D, regulatory, quality, and clinical teams.
• Translate strategy into roadmaps with timelines, milestones, and interdependencies.
• Support IDEs, pre-submissions, and other regulatory filings; manage governance updates.
• Identify risks and dependencies, escalate issues, and drive mitigation strategies.

Skills

Program Management

Regulatory Submissions

Design Controls (ISO 13485)

Software Lifecycle (IEC 62304)

NGS Diagnostics

Stakeholder Management

Risk Management

Executive Communication

Documentation & Traceability

Quality Systems

Education

PMP

Tools

Smartsheets

JIRA

Office Timeline

Job description

Jobtailor seeks a Program Manager to drive end-to-end product development in regulated environments, coordinating assays, software, and systems development with ISO 13485 and IEC 62304 compliance. You will manage planning, scheduling, resources, and risk across cross-functional teams, ensuring regulatory alignment.

Lead submissions readiness (IDE, 510(k), PMA), partner with external collaborators, and present data-driven recommendations to senior leadership to enable timely decisions.