Medical Device Auditor

United States Digital Space LLC; Greater London; On-site; GBP 75,000 - 90,000; Full time

Benefits offered by this job

Equity

Job summary

United States Digital Space LLC is seeking a Medical Device Auditor to audit manufacturers’ quality management systems against ISO 13485, EU MDR and UK MDR. You will learn our audit methods and deliver clear conclusions to support certification decisions.

The role involves reviewing records, interviewing teams, documenting evidence and communicating findings, with limited travel. You help bring safe devices to patients faster while upholding rigorous regulatory standards.

Qualifications

• A degree in a relevant scientific, engineering or medical discipline.
• At least four years’ experience in the medical device industry, including two years auditing or managing an ISO 13485 QMS.
• Working knowledge of EU MDR or UK MDR requirements for quality management systems.
• Experience explaining audit findings or regulatory requirements clearly, in writing and in conversation.
• Experience with software demonstrating knowledge of software design, validation, testing, debugging and interactions with its operating environment.

Responsibilities

• Plan and conduct QMS audits against ISO 13485, EU MDR and UK MDR requirements.
• Review records and interview teams to assess whether their processes meet the requirements.
• Document evidence, findings and conclusions in clear, timely audit reports.
• Explain findings constructively and keep customers informed throughout the audit.
• Review corrective actions and the evidence needed to close findings.

Skills

QMS audits

ISO 13485

EU MDR

UK MDR

Audit reporting

Regulatory communication

Interviewing teams

Education

Degree in science/engineering/medical discipline

Tools

Software development tools

Job description

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

the company 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 roleAs a Medical Device Auditor at the company, you will audit medical device manufacturers’ quality management systems and produce clear conclusions that support certification decisions. You’ll receive training in the company’s audit methods and tools. Your work will combine reviewing evidence with conversations about how manufacturers’ processes work in practice. Travel will be limited, though occasional trips may be required. You will help safe devices reach patients sooner.

Responsibilities

• Plan and conduct QMS audits against ISO 13485, EU MDR and UK MDR requirements.

• Review records and interview teams to assess whether their processes meet the requirements.

• Document evidence, findings and conclusions in clear, timely audit reports.

• Explain findings constructively and keep customers informed throughout the audit.

• Review corrective actions and the evidence needed to close findings.

Required qualifications

A degree in a relevant scientific, engineering or medical discipline.

• At least four years’ experience in the medical device industry, including two years auditing or managing an ISO 13485 QMS.

• Working knowledge of EU MDR or UK MDR requirements for quality management systems.

• Experience explaining audit findings or regulatory requirements clearly, in writing and in conversation.

• Experience with software demonstrating knowledge of software design, validation, testing, debugging and interactions with its operating environment.

Preferred qualifications

• Experience conducting audits for a certification or notified body.

• Experience with medical device software.

Interview process

• Introductory call with Sandy — 30 minutes.

• QMS audit exercise and discussion with Felicia — 60 minutes.

• Culture and values interviews with James and Jamie — 30 minutes each.

• References and offer.

Compensation: £75K – £90K Offers Equity