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
#J-18808-Ljbffr
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
#J-18808-Ljbffr
