Remote Global Regulatory & Labeling Program Manager

Kaygen, Inc.; Milpitas (CA); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Free Healthcare Insurance

401(k) Retirement Plan

Free Life Insurance

Sick Time Off

Job summary

Kaygen, Inc. is seeking a Project/Program Manager in Milpitas, CA (Remote) to support global regulatory registration and labeling transitions within the Biosciences organization.

You will own workstreams across regions and product groups, coordinating across Regulatory Affairs, Quality, R&D, Labeling, Product, Operations, IT, and Supply Chain. The role emphasizes execution discipline, data management, and clear cross-functional communication, enabling timely milestones and governance decisions.

Qualifications

• Bachelor's degree in business, science, engineering, regulatory affairs, operations, or related field.
• Six or more years of project or program management in a regulated environment.
• Experience in medical devices, IVD, biotechnology, pharmaceuticals, or similar life-sciences.
• Proven ability to develop and maintain project plans with milestones, risks, and decisions.
• Familiarity with dossiers, design controls, quality systems, labeling, submissions, or compliance remediation.

Responsibilities

• Lead assigned workstreams or execution packages, converting objectives into deliverables, milestones, owners, dependencies, and dates.
• Build and maintain detailed project plans across regulatory, labeling, quality, IT, operations, and commercial activities.
• Coordinate deliverables across functions and regions; monitor commitments and close actions in a matrix environment.
• Maintain risks, actions, issues, decisions, assumptions, and dependencies; escalate material impacts as needed.
• Facilitate planning sessions and readiness reviews; document decisions and owners with due dates.
• Support dossier readiness and submissions by coordinating reviews, gaps, remediation, and dependencies.

Skills

Excel

PowerPoint

Power BI

MS Project / Planning tools

Stakeholder management

Cross-functional coordination

Data management

Attention to detail

Communication skills

Education

Bachelor's degree in business/science/engineering/regulatory affairs

PMP certification

Tools

Smartsheet

Microsoft Project

SharePoint

Teams

Job description

Kaygen, Inc. is seeking a Project/Program Manager in Milpitas, CA (Remote) to support global regulatory registration and labeling transitions within the Biosciences organization.

You will own workstreams across regions and product groups, coordinating across Regulatory Affairs, Quality, R&D, Labeling, Product, Operations, IT, and Supply Chain. The role emphasizes execution discipline, data management, and clear cross-functional communication, enabling timely milestones and governance decisions.