Contract PM for Medical Devices – Cross-Functional Lead

Randstad USA; Dublin (CA); On-site; USD 83,000 - 92,000; Full time

Job summary

Randstad Engineering in Dublin, CA is seeking a seasoned Program Manager for a contract role. You will serve as the central program leader, driving alignment and execution across R&D, regulatory, quality, operations, and marketing teams, with emphasis on FDA-regulated medical device programs.

The ideal candidate brings 8+ years in a regulated medical device setting and has FDA 510(k) experience. This contract role runs at least 6 months and may extend, with 9am-5pm hours on-site in Dublin, CA.

Qualifications

• 8+ years of Program Management experience in a highly complex regulated medical device environment.
• FDA 510(k) global regulatory experience.

Responsibilities

• Direct programs through R&D, regulatory submission, commercial launch, and post-launch scale-up.
• Enforce Prometh+ development processes, design controls, and phase gate reviews.
• Unify Product Management, R&D, Regulatory, Quality, Operations, and Marketing teams.
• Coordinate regulatory submissions, clinical trial execution, and product approvals.
• Lead operational launch planning across manufacturing, supply chain, training, and customer service.
• Manage change control, system requirements, verification, validation, and risk management.
• Build and track integrated project plans, critical path milestones, and team resource allocation.

Skills

Program Management

Regulatory Affairs

Leadership

FDA 510(k)

Education

Bachelor's degree

Job description

Randstad Engineering in Dublin, CA is seeking a seasoned Program Manager for a contract role. You will serve as the central program leader, driving alignment and execution across R&D, regulatory, quality, operations, and marketing teams, with emphasis on FDA-regulated medical device programs.

The ideal candidate brings 8+ years in a regulated medical device setting and has FDA 510(k) experience. This contract role runs at least 6 months and may extend, with 9am-5pm hours on-site in Dublin, CA.