Quality Assurance & Regulatory Affairs Specialist

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

About Pangaea Data Limited

Pangaea Data (Pangaea) is a provider of a clinically validated AI platform that proactively uncovers care gaps, which cannot be pre-empted or prompted for because they are unknown, thereby delivering reliable, actionable insights that enable earlier intervention, improve quality and patient safety, and make advanced clinical decision support accessible across both high and low resource settings. Pangaea's founders Dr Vibhor Gupta and Prof Yike Guo (Director Data Science Institute at Imperial College London; Provost, Hong Kong University of Science and Technology) have worked in medicine and computing for over 20 years and have raised over $300 million through their academic research, including a $110 million grant focused on development work on large language models in medicine. Their advisors include industry veterans from healthcare and the life sciences, including Lord David Prior (former chairman, NHS England) and Mr. Andy Palmer (former CIO, Novartis).

About Pangaea Data Limited

Pangaea Data (Pangaea) is a provider of a clinically validated AI platform that proactively uncovers care gaps, which cannot be pre-empted or prompted for because they are unknown, thereby delivering reliable, actionable insights that enable earlier intervention, improve quality and patient safety, and make advanced clinical decision support accessible across both high and low resource settings. Pangaea's founders Dr Vibhor Gupta and Prof Yike Guo (Director Data Science Institute at Imperial College London; Provost, Hong Kong University of Science and Technology) have worked in medicine and computing for over 20 years and have raised over $300 million through their academic research, including a $110 million grant focused on development work on large language models in medicine. Their advisors include industry veterans from healthcare and the life sciences, including Lord David Prior (former chairman, NHS England) and Mr. Andy Palmer (former CIO, Novartis).

The Role

As Pangaea's Quality Assurance & Regulatory Affairs Specialist, you'll own the day-to-day running and continuous improvement of our established Quality Management System, keeping it effective as the company grows. This role is designed for a quality professional with some regulatory exposure who wants to deepen their regulatory expertise and grow into a broader QA/RA leadership role over time.

Key Responsibilities

Quality Management

• Maintain and continuously improve our QMS in line with ISO 13485, 21 CFR Part 820, and other relevant standards.
• Manage core quality processes, including document control, CAPA, nonconformances, complaints, supplier management, and change control.
• Plan and conduct internal audits, and support the business through external audits and inspections by certification bodies and regulators.
• Maintain and update standard operating procedures and compliance documentation.
• Track quality metrics and identify opportunities to make processes more efficient and fit for purpose.

Regulatory Affairs

• Support the company’s journey to CE marking under the EU MDR, including preparation of technical documentation and readiness for notified body conformity assessment.
• Help coordinate responses to notified body questions and support audits throughout the certification process.
• Contribute to risk management (ISO 14971) and software lifecycle (IEC 62304) documentation alongside product and engineering teams.
• Monitor relevant regulatory and standards changes and help assess their impact on our products and processes.
• Take on increasing responsibility for regulatory activities as your knowledge and experience develop.

Training & Collaboration

• Deliver QMS training and onboarding so all teams understand and follow quality and regulatory requirements.
• Act as the go-to person for day-to-day quality questions across the organisation.
• Work closely with biomedical, clinical, engineering, and marketing teams to embed quality into every phase of development.
• Communicate quality and regulatory requirements clearly to non-specialist colleagues.

Requirements

Personal Traits

• A genuine curiosity about regulatory affairs and a strong drive to learn and grow in the field.
• Clear communicator, able to explain quality and regulatory concepts to technical and non-technical colleagues.
• Organised and detail-oriented, with a pragmatic approach to keeping processes compliant without making them burdensome.
• Collaborative team player who enjoys working across engineering, clinical, marketing, and leadership teams.

Must Haves

• Experience in quality assurance within the medical device, diagnostics, or digital health industry (typically 2-5 years).
• Hands-on experience operating within an ISO 13485 certified QMS, including processes such as CAPA, document control, and internal audits.
• Some exposure to regulatory affairs, such as contributing to technical documentation, submissions, or regulatory assessments.
• Working knowledge of ISO 13485 and ISO 14971, with familiarity with IEC 62304 or a willingness to learn it quickly.
• Experience supporting external audits by notified bodies, certification bodies, or regulators.

Nice To Have

• Experience with EU MDR technical documentation or notified body conformity assessment.
• Awareness of regulatory considerations for AI/machine learning in medical devices, including the EU AI Act.
• Exposure to other SaMD regulatory pathways (e.g. FDA 510(k)/De Novo, UKCA).
• Internal auditor or lead auditor qualification.
• Experience in a MedTech or health tech company, ideally in a fast-paced or startup environment.
• Familiarity with cybersecurity, data privacy, or clinical evaluation requirements for digital health products.

Perks and Benefits

• Benefits include private medical insurance, life insurance and travel cards.
• You would join a small, dedicated and fast-growing team.
• You will have the opportunity to learn about building a startup business from experienced professionals and serial entrepreneurs.
• We are currently supported by serial entrepreneurs and angel investors. You will have the opportunity to experience an investment life cycle for a startup and meet leading venture capitalists.

General Information

Pangaea Data is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.