Project Coordinator - IT - III*

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

Job Title: Project Coordinator - IT - III

Location: Foster City, CA 94404 (Mostly Remote, with 10% travel)

Duration: 12 Months

The Device Engineering team at this company is seeking a qualified individual to support drug device combination products throughout the commercial lifecycle. This individual will be responsible for the management of combination product change records. Additional responsibilities include post market surveillance reports, risk management file maintenance, and general project management across the combination product portfolio.

Job Responsibilities

• Coordinate and manage combination product change control records:
  • Initiate, route, and close change records for product and manufacturing process changes.
  • Initiate, route, and close change records for the design and development of drug device combination products, including the creation and management of design control documentation.
  • Manage implementation of changes at multiple manufacturing sites and change record closures.
• Coordinate post-market surveillance reports and risk management file updates:
  • Collate surveillance information into yearly reports.
  • Generate annual risk summaries and update risk management files.
• Support complaint investigations and documentation.
• Act as a central hub between cross-functional teams to ensure supply continuity.

Knowledge & Skills

• Exceptional organizational and time management skills.
• Understanding of change controls in a regulated industry.
• Experience with project management.
• Working knowledge of relevant US, EU, and international medical device and pharmaceutical regulations.
• Experience with Veeva Vault.
• Ability to work with team members, vendors, suppliers, and contract manufacturers to coordinate changes.

Education & Experience

• 3 - 5 years relevant experience in related field and a BS or BA.
• Experience with medical device development and / or pharmaceutical operations (cGMP environment) required.