Global IVD Regulatory Affairs Specialist II (Contract)

Us Tech Solutions; Fremont (CA); On-site; USD 38,000 - 53,000; Full time

Job summary

US Tech Solutions in Fremont, CA seeks a Regulatory Affairs Specialist II to draft and file regulatory submissions for IVD products and support international registrations. You will prepare technical files for CE marking and coordinate with global teams to obtain approvals and renewals.

The role requires a Bachelor's degree in a scientific/engineering field, 2+ years in regulatory roles, and strong communication skills to navigate regulatory requirements and documentation standards.

Qualifications

• Bachelor's degree in a scientific, engineering or related field.
• 2+ years in regulatory environment – RA/QA/R&D/QC.
• Working knowledge of IVD products.
• Knowledgeable in regulatory strategy creation, design control, cGMP/Quality Systems, IVDR and import/export requirements.
• Strong oral and written communication skills.

Responsibilities

• Draft, assemble, and file regulatory submissions for new or existing products.
• Support international registration of IVD products.
• Prepare and maintain product technical files for CE marking.
• Coordinate with international counterparts for approvals and renewals.
• Organize and maintain regulatory documentation per procedures.

Skills

Regulatory affairs

IVD knowledge

Regulatory writing

Design control

Communication skills

Education

Bachelor's degree (science/engineering)

Job description

US Tech Solutions in Fremont, CA seeks a Regulatory Affairs Specialist II to draft and file regulatory submissions for IVD products and support international registrations. You will prepare technical files for CE marking and coordinate with global teams to obtain approvals and renewals.

The role requires a Bachelor's degree in a scientific/engineering field, 2+ years in regulatory roles, and strong communication skills to navigate regulatory requirements and documentation standards.