Katalyst CRO ยท 13 hours ago
Project Manager
Santa Rosa, CA
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is seeking an experienced Project Manager with a strong background in the medical device industry. The role involves leading cross-functional initiatives, managing complex projects, and ensuring compliance with FDA regulations while driving operational excellence.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead end-to-end project management for medical device operations and manufacturing initiatives
Partner with Operations, Manufacturing, Supply Chain, Quality, and Engineering teams
Manage project scope, schedule, budget, risks, and dependencies
Drive process improvements across production, supply chain, and operational workflows
Ensure compliance with FDA regulations, GMP, and ISO 13485 standards
Track KPIs, analyze data, and present insights to stakeholders
Coordinate supplier-related and production planning activities
Deliver projects on time while maintaining quality and regulatory compliance
Qualification
Required
5+ years of Project Management experience in the US
Experience within Medical Devices / Life Sciences / Regulated Manufacturing
Strong knowledge of Manufacturing Operations
Strong knowledge of Supply Chain & Vendor Management
Strong knowledge of Production Planning & Process Improvement
Familiarity with FDA, GMP, ISO 13485 environments
Strong analytical skills with ability to work with data and drive insights
Excellent communication and cross-functional collaboration skills
Ability to work 100% onsite at Santa Rosa, CA or Minneapolis, MN
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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