Summary:
Full-time | Regulated Industry (IVD/Medical Devices)
Veracyte is seeking a Project Manager to lead cross-functional teams in the development and commercialization of diagnostic products. This role is responsible for delivering complex projects on time, within budget, and in compliance with ISO 13485, FDA, IVDR, and other regulatory standards. The position requires strong leadership, planning, and stakeholder management in a fast-paced, highly regulated environment.
Key Responsibilities:
- Manage diagnostic product development projects from feasibility to commercialization
- Lead cross-functional teams (R&D, QA/RA, Clinical, Manufacturing, Commercial)
- Align project plans with global regulatory and quality requirements (e.g., ISO 13485, IVDR, FDA 510(k)/PMA)
- Develop timelines, risk registers, and mitigation plans
- Present status and strategy updates to executive leadership
- Support creation of QMS documentation and stage-gate reviews
- Help improve PMO tools, processes, and resource planning
- Contribute to portfolio alignment and strategic planning
Qualifications:
- 5+ years of project management experience in IVD, diagnostics, or medical devices
- Bachelor’s or Master’s in life sciences, engineering, or related field
- Strong understanding of regulatory pathways and product lifecycle under ISO 13485
- Skilled in project management tools (Smartsheet preferred)
- PMP or equivalent certification preferred
- Excellent communication, leadership, and collaboration skills
- Comfortable operating in ambiguous, fast-paced environments
Job sourced from Veracyte.