MedTech QA & Regulatory Affairs Specialist - Startup

Pangaea Data Limited; South San Francisco (CA); On-site; USD 110,000 - 165,000; Full time

Benefits offered by this job

Private medical insurance

Life insurance

Travel cards

Startup exposure

Job summary

Pangaea Data Limited is seeking a Quality Assurance & Regulatory Affairs Specialist to own the day-to-day QMS operations and drive continuous improvement as the company scales.

You will lead ISO 13485 compliance, CAPA, internal audits, and regulatory submissions (CE/MDR, IEC 62304), partnering with engineering, clinical, and leadership teams.

This is a hands-on role in a fast-growing MedTech startup with strong mentorship and opportunities to shape regulatory strategy.

Qualifications

• Experience in quality assurance within medical device, diagnostics, or digital health.
• Exposure to regulatory affairs activities such as technical documentation or submissions.
• Familiarity with ISO 13485 and ISO 14971; willingness to learn IEC 62304 quickly.

Responsibilities

• Maintain and continuously improve the QMS in line with ISO 13485, 21 CFR Part 820, and other standards.
• Support regulatory affairs activities including CE marking under EU MDR and conformity assessment readiness.
• Deliver QMS training and onboarding; collaborate with engineering, clinical, marketing and leadership teams.

Skills

Quality Assurance

Regulatory Affairs

ISO 13485

Internal Audits

Documentation

Communication

Cross-functional collaboration

Job description

Pangaea Data Limited is seeking a Quality Assurance & Regulatory Affairs Specialist to own the day-to-day QMS operations and drive continuous improvement as the company scales.

You will lead ISO 13485 compliance, CAPA, internal audits, and regulatory submissions (CE/MDR, IEC 62304), partnering with engineering, clinical, and leadership teams.

This is a hands-on role in a fast-growing MedTech startup with strong mentorship and opportunities to shape regulatory strategy.