Lead Auditor - Contractor role
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Key skills for this role
Role Overview
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.
Key Skills for This Role
Full Job Posting
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
- 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
- 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.
- 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
- 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
- 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
- Experience with software medical devices (SaMD) is strongly preferred
- Working knowledge of relevant standards, such as: ISO 14971 IEC 62304 IEC 82304 Cybersecurity
- 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)
Complete a case study (maximum 60 min)
Present the case study (30 min)
References
Offer & onboarding
About Scarlet
UK medical-device certification body helping software and AI medical-device manufacturers reach market.
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