Immediate need for a talented Senior Project Manager – Regulatory Affairs (Medtech). This is a 12+ Months Contract opportunity with long-term potential and is located in Milpitas, CA (Remote). Please review the job description below and contact me ASAP if you are interested.
Job ID:26-34045
Pay Range: $75 - $80/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- Lead assigned projects and workstreams, translating program objectives into clear scope, deliverables, milestones, owners, dependencies, and target dates.
- Build and maintain integrated project plans that align regulatory, technical documentation, labeling, quality, R&D, operations, supply chain, commercial, and IT activities.
- Coordinate across functional leaders and subject matter experts, monitor commitments, resolve planning gaps, and drive completion of deliverables in a matrix environment.
- Identify and manage risks, issues, actions, decisions, assumptions, schedule conflicts, and resource constraints.
- Assess the downstream impact of changes and delays, establish mitigation plans with accountable owners, and escalate material items through appropriate governance channels.
- Facilitate cross-functional planning sessions, working meetings, risk reviews, and decision discussions.
- Ensure meeting outcomes, approved decisions, and changes are reflected in project plans, reporting, and communications.
- Apply working knowledge of technical dossiers, design controls, labeling, quality systems, and regulatory submissions to support appropriate planning, sequencing, documentation readiness, and submission readiness.
- Prepare concise status updates for project teams and leadership, highlighting progress, upcoming milestones, overdue actions, risks, dependencies, decisions, and required support.
- Design and maintain practical project databases, trackers, dashboards, and reporting processes.
- Consolidate information from multiple workstreams and analyze project data to identify trends, emerging risks, and areas requiring leadership attention.
- Improve the quality, consistency, and efficiency of program reporting, including opportunities to simplify or automate recurring data collection.
Key Requirements and Technology Experience:
- Top Must Have’s : Mergers & Acquisitions: Led or supported post-merger integration, business integration, or acquisition-related transition programs.
- Global team management: Coordinated cross-functional teams across multiple countries, business units, and time zones.
- PMP certification: Holds an active Project Management Professional (PMP) certification.
- Product registration and regulatory submissions: Experience coordinating regulatory registration, submission readiness, and technical documentation.
- Product labeling: Managed labeling transitions, labeling updates, or labeling compliance as part of regulated product launches or transitions.
- Bachelor’s degree in business, science, engineering, operations, information systems, or a related discipline.
- Ten or more years of progressive project or program management experience.
- Experience managing complex, cross-functional projects or workstreams in a regulated life sciences environment.
- Demonstrated experience managing integrated plans, milestones, dependencies, risks, issues, decisions, and accountability across multiple functions.
- Working knowledge of technical dossiers, design controls, labeling, quality systems, and regulatory submission processes.
- Strong analytical and data management capabilities, including experience developing project databases, dashboards, and data-driven reporting solutions.
- Advanced proficiency with Excel and strong proficiency with Power BI or a comparable data visualization tool.
- Proficiency with PowerPoint, Teams, SharePoint, and project planning or collaboration tools.
- Strong written, verbal, facilitation, presentation, and stakeholder management skills.
- Ability to influence and drive accountability without direct authority.
- Direct experience supporting global medical device or in vitro diagnostic product registrations or re-registrations.
- Experience supporting regulatory submissions, technical documentation readiness, labeling transitions, or compliance remediation programs.
- Experience with business integration, transformation, M&A, or other enterprise-level initiatives.
- Experience working with global teams across multiple functions, regions, or business units.
- PMP, PgMP, or equivalent project management certification.
- Independently structures ambiguous work and drives it to completion.
- Balances detailed workstream execution with broader program priorities and changing requirements.
- Translates project data into clear insights, decisions, and actions.
- Uses sound judgment in issue resolution, escalation, and prioritization.
- Manages multiple priorities effectively in a fast-moving environment.
- Maintains high standards for detail, data quality, and reporting accuracy.
Our client is a leading Medical Devices Manufacturing Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
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