Documentation Specialist

VARITE • Fremont, CA

2d • Onsite

About The Position

The Regulatory Affairs Specialist II will support the international registration of in vitro diagnostic (IVD) products. The role drafts, assembles, and files documentation and submission materials for new or existing products, ensuring submissions are accurate, high quality, supported by literature and regulatory foundations, organized to facilitate review, and compliant with applicable statutes, regulations, and guidelines.

The specialist will join an existing team and coordinate regulatory information and documents for various purposes. Responsibilities include preparing and maintaining product technical files for CE marking, preparing international submissions, coordinating with international counterparts to obtain product approvals and renewals, and maintaining regulatory documentation in accordance with department and company procedures. This is an onsite, 12-month contract in Fremont, California, with a possible extension.

Requirements

• Bachelor’s degree in a scientific, engineering, or related field.
• At least 2 years of experience working in a regulatory environment, such as RA, QA, R&D, or QC.
• Working knowledge and experience with IVD products.
• Knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, IVDR, and import/export requirements.
• Strong oral and written communication skills.

Responsibilities

• Initiate, collect, and coordinate information for regulatory documents.
• Prepare and maintain product technical files for CE marking.
• Organize and prepare documentation for international submissions, including drafting reports.
• Coordinate with international counterparts to obtain product approvals and renewals.
• Maintain regulatory logs and trackers.
• Organize, update, and maintain regulatory documentation in accordance with department and company procedures.

Benefits

• Medical, dental, and vision coverage.
• Participation in a company-sponsored retirement savings plan.
• Legal service plans providing access to attorneys for advice and representation.
• Potential eligibility for an employee referral bonus.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level