Regulatory Administrative Assistant (Hybrid - Sunnyvale, CA)

***Please note that our customer is currently not considering applicants from the following locations: Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.***

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

We are seeking a Regulatory Administrative Assistant on a contract basis to support our Customer's business needs. This role is a hybrid setup (3 days on-site and 2 days remote/week) in Sunnyvale, CA.

This role provides critical administrative and coordination support to the Regulatory Affairs team, enabling them to focus on core regulatory responsibilities. This role involves data analysis, report preparation, document handling, and cross-functional communication.

Responsibilities:

• Create, maintain, and update project trackers
• Compile data and generate reports for internal and external use
• Prepare, update, and archive regulatory documentation
• Schedule and organize meetings, including:
• Note-taking
• Distribution of meeting minutes
• Assist the Regulatory Submissions team by:
• Creating Engineering Change Orders (ECOs)
• Entering data into product registration databases
• Supporting documentation release and archival
• Perform administrative tasks in a fast-paced, deadline-driven environment
• Coordinate cross-departmental and external party activities
• Review and update work instructions and procedures related to regulatory submissions
• Manage purchase orders and invoice payments for the Regulatory Affairs department

Qualifications

• High school diploma or equivalent and 5 years of relevant on-the-job training or experience OR BS/BA and 4 years of relevant experience
• Strong written and verbal communication skills
• Effective time management and organizational abilities
• High attention to detail and strong self-motivation
• Ability to collaborate with individuals across varying skill levels
• Dependable follow-through on assigned tasks

Technical:

• Proficiency in Microsoft Word and Excel (beyond basic data entry)
• Familiarity with formatting, version control, redlining documents
• Experience with Agile and Veeva platforms is a plus (training provided)
• Familiarity with Smartsheet and other tracking tools is beneficial

Soft Skills:

• Strong attention to detail
• Excellent communication skills
• Quick to respond and adaptable
• Self-motivated and able to work independently
• Team-oriented and open to learning

Preferred:

• Project management experience
• Familiarity with FDA websites or regulatory databases
• Medical Device background a plus

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements) Benefits include: Medical, Dental, Vision, 401k.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.CooRegulatory Administrative Assistant