Technical Specialist / Data Analyst

Technical Specialist / Data Analyst

Location: Foster City, CA (onsite)

JD:

Technical Specialist 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.

Requirements:

• 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.