AI-Optimized Job Summary:
Spec 2,
Project/Program Management Location:
Milpitas, CA (On-site preferred; remote considered for exceptional candidates)
Compensation:
$70
- 80/hr | Contract | PST hours preferred About the Role Drive global impact as a Project/Program Manager supporting a high-visibility labeling and registration transition for a global biosciences leader (Project Artemis).
You'll collaborate with cross-functional and regional teams to deliver complex regulatory, product, and operational programs end-to-end. This is an opportunity to gain exposure to cutting-edge life sciences integration, work alongside seasoned experts, and build a track record in regulated medical device and IVD environments. Responsibilities
- Lead and own assigned project workstreams, translating objectives into actionable deliverables, milestones, and schedules.
- Build and maintain detailed project plans for regulatory, technical, labeling, quality, and operational activities.
- Coordinate cross-functional and regional stakeholders for seamless program execution; follow up on actions and ensure accountability.
- Track and maintain risks, actions, issues, and decisions; escalate critical concerns and dependencies through governance.
- Facilitate meetings, planning sessions, and readiness reviews; document and track decisions, ownership, and deadlines.
- Support technical documentation readiness by coordinating reviews and addressing submission dependencies.
- Manage and reconcile high-volume product, SKU, country, and registration data to ensure accuracy and completeness.
- Deliver concise status updates and dashboards highlighting milestones, risks, and action items.
- Implement process improvements to enhance project controls, data quality, and reporting consistency. Required Skills and Experience
- Bachelor's degree in business, engineering, science, regulatory affairs, operations, information systems, or related field.
- Minimum of six years' project/program management in a regulated environment (medical device, IVD, biotech, pharma, or similar).
- Track record of developing and executing detailed project plans, managing risks, milestones, and dependencies.
- Familiarity with technical dossiers, design controls, labeling, regulatory submissions, and compliance.
- Demonstrated ability to drive cross-functional deliverables and accountability in a matrix structure.
- Advanced data management and analytical skills; strong proficiency in Excel, PowerPoint, Teams, SharePoint, project-planning tools.
- Excellent organization, facilitation, stakeholder management, and written communication. Preferred Skills
- Experience supporting global medical device or IVD registrations, labeling transitions, or compliance remediation.
- Skilled in managing large datasets for product, SKU, registration, and lifecycle management.
- Experience with Smartsheet, MS Project, Power BI, PLM, or document management tools.
- Prior involvement in business integration, transformation, or M&A projects.
- PMP, CAPM, or equivalent certification. Benefits
- Work on a mission-critical global program with executive visibility.
- Flexible work options (on-site preferred; remote considered for top candidates).
- Competitive hourly compensation.
- Collaborate with world-class teams in biosciences and regulated industry.
- Opportunity to expand your expertise in global program management and compliance.
How to Apply Ready to drive global change in biosciences? Submit your resume and a brief cover letter highlighting your experience in regulated project/program management. Qualified applicants will be contacted promptly for next steps.