Program Manager

Jobtailor

Boulder (CO)

On-site

USD 120,000 - 170,000

Full time

14 days+

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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

Drive end-to-end execution of product development programs, including planning, scheduling, resource coordination, and risk management across assay, software, and systems development, ensuring alignment with regulatory and business requirements.
Support regulatory product development activities, ensuring alignment with regulated processes and quality systems, including design control processes (ISO 13485), software lifecycle standards (IEC 62304), change management, and quality system requirements (FDA, CAP/CLIA), including documentation and traceability of requirements and deliverables.
Coordinate regulatory submission readiness, including support for Investigational Device Exemptions (IDEs), pre-submissions, and other global regulatory filings.
Lead cross-functional alignment across R&D, software, regulatory, quality, and clinical teams to ensure clear requirements, priorities, and deliverables.
Translate product strategy into actionable program roadmaps, including timelines, milestones, and interdependencies, ensuring alignment with organizational priorities and securing stakeholder buy-in.
Extract and refine user needs and requirements from stakeholders and lead teams to focus on the most valuable deliverables.
Partner with Alliance Management to manage external biopharma and CDx partnerships, coordinating joint program plans, deliverables, timelines, and communication across organizations.
Adhere to formal governance processes to communicate program status, risks, and trade-offs; escalate issues as needed; and present data-driven recommendations and business proposals to senior leadership to enable timely, informed decision-making.
Identify, track and manage program risks and dependencies, proactively identifying mitigation strategies and driving issue resolution.
Drive cross-functional accountability, influencing without direct authority to ensure alignment, ownership, and timely execution.
Support continuous improvement of product development processes, tools, and cross-functional ways of working.
Cultivate, build and maintain positive and collaborative relationships with cross-functional teams.

Requirements

3-5+ years of experience in program management, or equivalent combination of project management and relevant functional experience in biotechnology, diagnostics, clinical laboratory, or life sciences.
Experience supporting product development in regulated environments (IVD, medical device, or similar).
Background in NGS diagnostics, including assay and software components (MRD experience preferred).
Strong familiarity with design controls (ISO 13485) and software lifecycle processes (IEC 62304).
Experience supporting regulatory submissions (e.g., IDE, 510(k), PMA, or equivalent) preferred.
Exposure to clinical trial operations and execution (preferred).
Experience working with external partners, such as biopharma or CDx collaborations (preferred).
PMP or equivalent certification preferred.
Ability to influence senior stakeholders and drive alignment in matrixed organizations.
Strong organizational and program management skills, with the ability to manage multiple concurrent initiatives.
Analytical mindset with strong attention to detail and ability to identify risks and dependencies.
Excellent executive communication skills, with the ability to tailor messaging across technical and non-technical audiences.
Proficiency with program management and collaboration tools (e.g., Smartsheets, JIRA, Office Timeline, etc.).
Situational awareness, coupled with facilitation, problem solving, and conflict resolution skills to drive cross-functional decision-making.
This position may be required to work across time zones as needed to support project schedules.

Core Competencies

Demonstrates expertise in program management within regulated environments, particularly in biotechnology and diagnostics, with a strong focus on product development processes, regulatory compliance, and cross-functional collaboration. Proven ability to influence stakeholders and drive alignment across diverse teams while managing multiple initiatives effectively.

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