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Medical Device Company in Milpitas, CA seeks a Senior Project/Program Manager to drive a global regulatory registration and product transition initiative on a 1-year, W2 contract. Onsite in Milpitas with possible remote consideration for exceptional candidates operating on Pacific Time.
The role requires 10+ years in program management within regulated life sciences, a Bachelor's degree, and PMP certification.
Company: Medical Device Company
Role: Senior Project/Program Manager
Location: Milpitas, CA
Contract: 1 year W2 Contract (chance for extension)
Pay rate: 78/hour
Start date: estimated 11/2/2026
Medical, Dental and Vision Benefits
A leading biosciences organisation is seeking a Senior Project/Program Manager to drive a major global regulatory registration and product transition initiative, as well as other strategic integration projects. This is a one-year contract role based in Milpitas, California, with an onsite requirement; however, remote work may be considered for exceptional candidates able to operate on Pacific Time.
The Senior Project/Program Manager will be responsible for integrating activities across regulatory, quality, technical, labeling, operational, commercial, and IT functions. You will translate program objectives into actionable plans, manage dependencies and risks, and ensure timely decision-making and accountability. The role requires strong leadership in a matrix environment, facilitating cross-functional planning sessions, risk reviews, and decision discussions. You will maintain reliable program data, reporting, and dashboards, consolidating information from multiple workstreams to identify trends and emerging risks.
To be successful, you must have at least ten years of progressive project or program management experience, preferably within a regulated life sciences environment. A bachelor's degree in business, science, engineering, operations, information systems, or a related discipline is required. PMP certification is essential. You should demonstrate expertise in integrated project planning, regulatory submissions, technical dossier management, quality and design controls, labeling transitions, and RAID (risks, actions, issues, decisions) management. Advanced proficiency in Excel and strong skills in Power BI or comparable dashboard tools are expected, along with experience using PowerPoint, Teams, SharePoint, and project-planning platforms.
Preferred qualifications include direct experience with global medical device or in vitro diagnostic product registrations, M&A integration, and working with large, global teams across multiple regions and business units. Strong analytical, facilitation, and stakeholder management skills are critical, as is the ability to influence and drive accountability without direct authority.
Must-Have Skills: integrated project planning, regulated life sciences, regulatory submission, technical dossier management, quality, design control, labeling, artwork project management
Nice-to-Have Skills: global medical device registrations, in vitro diagnostic registrations, technical dossier development, labeling management systems, quality management system, design control, change control, compliance remediation, product transitions, M&A integration, business transformation, global teams, Microsoft Planner, SharePoint data structures, Power Query, Power Automate, RAID management, schedule management, project data management, Microsoft Excel, Power BI, Microsoft PowerPoint, Microsoft Teams, SharePoint, Smartsheet, Microsoft Project
EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.