Regulatory Affairs Specialist II

Job overview

The Regulatory Affairs Specialist II role is onsite in Fremont, CA, and pays $30–$33 per hour on W-2. The contract is 12 months with a possible extension. The role supports international registration of in-vitro diagnostic products for a client described as a life science and clinical research company. The specialist prepares and coordinates regulatory documentation and submission materials to support accurate, complete product filings and approvals. The role maintains technical files and regulatory records, coordinates with international counterparts on approvals and renewals, and helps ensure submissions follow applicable statutes, regulations, guidelines, and company procedures.

What you'll do

• Initiate, collect, and coordinate regulatory information
• prepare and maintain product technical files for CE marking
• organize and prepare international submissions, including reports and supporting documents
• coordinate with international counterparts to obtain product approvals and renewals
• maintain logs and trackers
• update and maintain regulatory documentation according to department and company procedures.

What we're looking for

Skills & competencies

regulatory affairs specialist ii

regulatory documentation

ivd products

international registration

ce marking

product technical files

fremont ca

varite

12-month contract

$30–$33/hr

regulatory submissions

Work arrangement

• Weekend coverage required

Benefits & perks

• Eligible employees may receive medical, dental, and vision coverage
• a company-sponsored retirement savings plan
• and legal service plans.

Why this role

Pay is $30–$33 per hour on W-2. Requires a bachelor’s degree in a scientific, engineering, or related field, 2+ years in a regulatory environment, and working knowledge of IVD products.

About the employer

Varite, Inc is hiring for this role. Industry: Employment Placement Agencies. Sector: 56.