IT Project Coordinator - Medical Device Change Control

Spectraforce Technologies; San Mateo (CA); On-site; USD 75,000 - 105,000; Full time

Job summary

Spectraforce Technologies in Foster City, CA is seeking a Project Coordinator - IT - III to support the drug-device portfolio through the commercial lifecycle. You will manage combination product change records, coordinate design control documentation, and ensure changes are implemented across multiple manufacturing sites.

The role requires strong organizational skills, experience with change controls in regulated environments, and familiarity with Veeva Vault.

Qualifications

• 3–5 years relevant experience with a BS/BA.
• Experience with medical device development or pharma operations in a cGMP environment.
• Understanding of change controls in a regulated industry.

Responsibilities

• Coordinate and close change control records for product and manufacturing changes.
• Coordinate change records for design and development of drug-device products with design control docs.
• Coordinate post-market surveillance reports and update risk management files.
• Serve as central hub between cross-functional teams to ensure supply continuity.

Skills

Organizational skills

Change controls

Project management

Regulatory knowledge

Veeva Vault

Cross-functional collaboration

Education

BS or BA in related field

Tools

Veeva Vault

Job description

Spectraforce Technologies in Foster City, CA is seeking a Project Coordinator - IT - III to support the drug-device portfolio through the commercial lifecycle. You will manage combination product change records, coordinate design control documentation, and ensure changes are implemented across multiple manufacturing sites.

The role requires strong organizational skills, experience with change controls in regulated environments, and familiarity with Veeva Vault.