6386 - Technical Specialist / Data Analyst

Verista, Inc.•Foster City, CA

2d•$85,000 - $145,300•Onsite

About The Position

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Requirements

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.
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.

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.