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Indotronix

Spec 2, Project/Program Mgmt

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Job Description

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.

Benefits

  • Dental Insurance