Regulatory Affairs Specialist II

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Regulatory Affairs Specialist II

• Location: Fremont, California 94538
• Work model: On-site
• Posted 10 days ago
• Job ID: JPC - 211121

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Job Description

Position Summary

The Regulatory Affairs Specialist II will draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines

Key Responsibilities:

The Regulatory Affairs Specialist II will join existing team and provide support for International Registration of IVD products.

Tasks will include

• Initiation, collection, and coordination of information of regulatory documents for various purposes.
• Preparation and maintenance of product technical files for CE marking
• Organization and preparation of documents for international submissions, including drafting reports, and preparing documentation for submissions
• Coordination with international counterparts to obtain product approvals and renewals.
• Maintaining logs and trackers.
• Organize, update, and maintain regulatory documentation in accordance with department and company procedures.

Minimum Requirements:

• Bachelors degree in a scientific, engineering or related field is required
• 2+ years of experience working in regulatory environment -RA/QA/R&D/QC
• Working knowledge and experience with IVD products
• Knowledgeable in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, IVDR and import/export requirements
• Strong oral and written communication skills

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Job details

Job ID JPC - 211121

Location Fremont, California, United States

Work Model On-site

Experience 2-5 years

Industry Healthcare - Health Services

Pay Rate $33 (Hourly)

Posted October 9, 2026

Skills regulatory

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