Clinical Affairs Specialist III (Fremont, CA)

Work Schedule

Environmental Conditions

Job Description

What you will do

• Not limited to, draft and maintain Scientific Validity Reports, Performance Evaluation Plans and Reports, Summary of Safety and Performance, and Post-Market Performance Follow-Up plans and Reports in accordance with EU IVDR regulation for Toxicology and Therapeutic Drug Monitoring Assays, and Clinical Chemistry Controls.
• Update the SOPs and templates as necessary related to IVDR documentation, clinical evidence generation, and post-market follow-up.
• Prepare, review, and archive clinical documentation including study plans, protocols, forms, memos, monitoring reports, data summary, and close-out summaries for all sites involved in the ongoing clinical trial.
• Support clinical site coordination, including communication with investigators, site leads to ensure adherence to approved protocols and regulatory expectations.
• Compile, review, and summarize the clinical data to support regulatory submissions and PMPF activities.
• Manage documentation trackers and ensure traceability of all reports and supporting evidence in the electronic document management system.
• Collaborate cross-functionally with Quality, Regulatory and Research and Development to ensure consistency across technical documentation and clinical submissions.
• Contribute to state-of-the-art literature searches and summaries demonstrating scientific validity and intended purpose of the IVDs.
• Participate in internal and external audits, providing supporting evidence for documentation.
• Perform other duties as assigned to support regulatory readiness, IVDR compliance, and clinical deliverables.

Keys to Success:

• A bachelor’s or master’s degree with a preference for majors in Biological Sciences is required.
• Experience with an excellent understanding of EU IVD regulation and GCP a plus
• Must be able to write clear, understandable technical documentation
• Excellent writing and organizational skills with the ability to synthesize technical data into compliant reports.
• High attention to detail, skilled at managing multiple deliverables and collaborating across global time zones.
• Ability to work independently under minimal supervision while maintaining high quality output.
• Preference for candidate who can work on site at Fremont, California facility. Hybrid option available for strong candidate.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards