MedTech QA & Regulatory Affairs Specialist

Pangaea Data Limited; South San Francisco (CA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Private medical insurance

Life insurance

Travel cards

Job summary

Pangaea Data Limited is seeking a Quality Assurance & Regulatory Affairs Specialist to own day-to-day quality operations and help mature our QA/RA leadership as the company scales. You will manage the QMS, drive regulatory readiness, and collaborate across engineering, clinical, and product teams.

The role emphasizes ongoing improvement of our ISO 13485-based system, CAPA processes, internal audits, and support for regulatory submissions while preparing for CE marking and other regulatory

Qualifications

• Experience in QA within medical device, diagnostics, or digital health (2-5 years).
• Hands-on experience with ISO 13485 QMS processes (CAPA, document control, internal audits).
• Some regulatory affairs exposure (technical documentation, submissions).
• Familiarity with IEC 62304 or willingness to learn quickly.
• Experience supporting external audits by notified bodies/regulators.

Responsibilities

• Maintain and improve QMS aligned with ISO 13485 and 21 CFR Part 820.
• Coordinate CAPA, document control, nonconformances, and supplier management.
• Prepare for regulatory submissions and CE marking readiness.
• Support external audits by notified bodies and regulators.
• Deliver QMS training across the organization.

Skills

Quality assurance

Regulatory affairs

Regulatory documentation

Tools

ISO 13485

Job description

Pangaea Data Limited is seeking a Quality Assurance & Regulatory Affairs Specialist to own day-to-day quality operations and help mature our QA/RA leadership as the company scales. You will manage the QMS, drive regulatory readiness, and collaborate across engineering, clinical, and product teams.

The role emphasizes ongoing improvement of our ISO 13485-based system, CAPA processes, internal audits, and support for regulatory submissions while preparing for CE marking and other regulatory