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Technical Specialist / Data Analyst

Foster City, CA, US • Posted 4 hours ago • Updated 9 minutes ago

Contract Independent

Contract Corp To Corp

Contract W2

On-site

Fitment

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Job Details

Skills

JD
Change Control
Design Controls
Manufacturing
Surveillance
Risk Management
Documentation
Management
Project Management
Veeva
Business Analysis
Business Analytics
Medical Devices
Pharmaceutics
Good Manufacturing Practice
Oracle UCM
SANS
OM
WebKit
IMG

Summary

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.

Navnish kumar

Sr. IT Technical Recruiter

Stellent IT Phone:

Email: navnish
Gtalk: navnishom

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91022079
Position Id: 2026-49189
Posted 4 hours ago

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