Regulatory Affairs Specialist, Medical Devices – Irvine

Pro-Dex, Inc.; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Pro-Dex, Inc. in Irvine, CA is seeking a Regulatory and Compliance Specialist to support product development with regulatory inputs, strategies, and design control deliverables. The role ensures compliance with local, state, federal and international requirements for medical devices.

Responsibilities include preparing submissions, reports, and supporting audits, while maintaining procedures and supporting 510(k)/CE documentation. Travel is occasional; in-office position in Irvine.

Qualifications

• Knowledge of 21 CFR QSR/cGMPs and ISO 13485 required.
• Experience with MDSAP and EU/UK medical device regulations a plus.
• Proficiency in scientific technical writing.

Responsibilities

• Support Product development teams to deliver regulatory inputs, strategies, reports and other design control deliverables.
• Prepare QA/Regulatory reports and present status in review meetings.
• Prepare reports and documents necessary for Regulatory Agency submissions or in support of customer QARA needs.
• Perform research to determine Regulatory requirements of product markets.
• Support internal, agency and customer audits and any resulting nonconformity / improvement actions.
• Prepare and support deliverables for 510K and CE Marking submission documents and maintain records.
• Maintain current procedures and assist with changes to meet new regulatory requirements.

Skills

Regulatory affairs

cGMP knowledge

ISO 13485

MDSAP

Scientific writing

MS Word

Excel

Access

ERP systems

Analytical thinking

Communication skills

Regulatory strategy

Education

Bachelor of Science

Tools

MS Word

Excel

Access

ERP systems

Job description

Pro-Dex, Inc. in Irvine, CA is seeking a Regulatory and Compliance Specialist to support product development with regulatory inputs, strategies, and design control deliverables. The role ensures compliance with local, state, federal and international requirements for medical devices.

Responsibilities include preparing submissions, reports, and supporting audits, while maintaining procedures and supporting 510(k)/CE documentation. Travel is occasional; in-office position in Irvine.