Medical Device Lead Auditor - Freelance

Scarlet; United States; Teletrabalho; USD 110 000 - 165 000; Tempo parcial

Resumo da oferta

Scarlet is seeking a Freelance Medical Device Lead Auditor to independently deliver efficient, high-quality QMS audits for medical device manufacturers, in line with Scarlet’s standards and culture.

The role is part-time/contractor, fully remote with flexible scheduling depending on audit demand. Candidates must hold a Lead Auditor qualification and have experience with regulatory standards and notified bodies.

Qualificações

• Bachelor’s degree in one of the listed fields.
• Minimum 4 years of experience in the medical device industry.
• Minimum 2 years auditing or managing QMSs under ISO 13485, ISO 27001, ISO 42001, EU MDR or UK MDR.
• Prior work with notified bodies or accreditation bodies as a Lead Auditor.
• Knowledge of ISO 14971, IEC 62304, IEC 82304 and Cybersecurity.
• Ability to interpret and apply regulatory requirements reliably.

Responsabilidades

• Conduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, ISO 27001, ISO 42001, EU MDR and UK MDR.
• Provide clear, structured audit documentation and evidence-based conclusions.
• Contribute to consistent, high-quality audit experiences aligned with Scarlet’s methodology and values.

Conhecimentos

Auditing

QMS management

Regulatory interpretation

Formação académica

Bachelor’s degree in software engineering

Bachelor’s degree in computer science

Bachelor’s degree in physics or biophysics

Bachelor’s degree in biology or microbiology

Bachelor’s degree in chemistry or biochemistry

Bachelor’s degree in electrical, electronic, mechanical engineering or bioengineering

Bachelor’s degree in human physiology

Bachelor’s degree in medicine

Bachelor’s degree in pharmacy

Descrição da oferta de emprego

We pull medical technology from the future to solve human health.

Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigorous certification can keep pace with product development at the world’s most ambitious technology companies, without lowering the safety bar.

Our customers have cut a year or more from their certification timelines for new AI-enabled medical devices and shortened product-update cycles from months to weeks. You’ll join a team building the infrastructure that makes these outcomes repeatable at scale.

About the role

As a Freelance Medical Device Lead Auditor at Scarlet, you will independently deliver efficient, high-quality QMS audits that help innovative medical device companies meet the highest regulatory standards.

We’re expanding our auditor pool, and we're looking for part-time/contractor lead auditors who can independently deliver audits in line with Scarlet’s standards, approach and culture.

This role is suited for auditors who fulfil the relevant criteria to be authorised as a Lead Auditor in a Certification or Notified Body under ISO 13485, EU MDR and UK MDR. You will work flexibly, supporting audit delivery as part of Scarlet’s notified body activities. This is a fully remote role, with flexible scheduling, subject to audit demand and availability.

Responsibilities

• Conduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, ISO 27001, ISO 42001, EU MDR, and UK MDR.

• Provide clear, structured audit documentation and evidence-based conclusions.

• Contribute to consistent, high-quality audit experiences aligned with Scarlet’s audit methodology and values.

Required qualifications

• A bachelor’s degree in either:

  • software engineering
  • computer science
  • physics or biophysics
  • biology or microbiology
  • chemistry or biochemistry
  • electrical, electronic, mechanical engineering or bioengineering
  • human physiology
  • medicine
  • pharmacy

• Minimum 4 years of experience in the medical device industry

• Minimum 2 years of experience auditing or managing QMSs under:

  • ISO 13485
  • ISO 27001
  • ISO 42001
  • EU MDR and/or UK MDR

• Prior work with notified bodies or accreditation bodies as a Lead Auditor

• Working knowledge of relevant standards, such as:

  • ISO 14971
  • IEC 62304
  • IEC 82304
  • Cybersecurity

• Evidence of confidently interpreting and applying regulatory requirements.

• Evidence of delivering consistent, high-quality audits.

• Ability to explain findings and requirements clearly and constructively.

• Ability to deliver audits independently with minimal oversight.

• Willingness to adopt Scarlet’s values, audit methods and tooling.

Preferred qualifications

• Practical experience working with software.

• Experience with software medical devices (SaMD).

Interview process

• Introductory call with Emily (30 min)

• Auditor competence & regulatory interviews (2x30-45 min)

• References

• Offer & onboarding