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

Authorised by governments around the world to assess medical AI, we remove unnecessary delays from every regulatory approval we do so patients get devices from the future, today. We are proud to count the world’s most ambitious companies building medical technology as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue.

About the role

Scarlet’s Quality Team ensures that innovative medical device companies meet the highest regulatory standards. We support cutting-edge healthtech through efficient, high-quality QMS audits.

We’re expanding our auditor pool and are 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.

Your responsibilities

Conduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, 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 & experience

Education
- Bachelor’s degree in:
  - software engineering
  - computer science
  - physics or biophysics
  - biology or microbiology
  - chemistry or biochemistry
  - electrical, electronic, mechanical engineering or bioengineering
  - human physiology
  - medicine
  - pharmacy
Professional experience
- Minimum 4 years of experience in the medical device industry
- Minimum 2 years of experience auditing or managing QMSs under:
  - ISO 13485
  - EU MDR and/or UK MDR
- Preferred: Practical experience working with software.
Auditing experience
- Prior work with notified bodies or accreditation bodies as a Lead Auditor
Technical experience
- Experience with software medical devices (SaMD) is strongly preferred
- Working knowledge of relevant standards, such as:
  - ISO 14971
  - IEC 62304
  - IEC 82304
  - Cybersecurity

What we’re looking for

Strong regulatory judgement — you are confident in interpreting and applying regulatory requirements.
Consistency & quality focus — you care deeply about audit quality and repeatability.
Clear communicator — you explain findings and requirements clearly and constructively.
Independent & reliable — you can deliver audits with minimal oversight
Aligned mindset — you are open to adopting Scarlet’s values, audit methods and tooling.

Engagement model

Consultant auditor role
Fully remote
Flexible scheduling, subject to audit demand and availability

Interview process

Introductory call with Emily (45 min)
Auditor competence & regulatory interview with a Scarlet auditor (45 min)
Case study with Johan
- Complete a case study (maximum 60 min)
- Present the case study (30 min)
References
Offer & onboarding

Remote Jobs - YesRemoteJobs

Scarlet

Open Positions (3)

Commercial Relations - US

Clinical Specialist - Expert Roster

Lead Auditor - Contractor role

Company Details