MDR Lead Auditor

Job description

Freelance MDR Lead Auditor / Technical Documentation Reviewer

EU Regulation 2017/745 (MDR) – Notified Body Experience Essential

ECM is seeking experienced freelance professionals for:

• Lead Auditor (MDR 2017/745)
• Technical Documentation Reviewer / Product Assessor
• or a combined Auditor & Technical Reviewer role

This opportunity is strictly for professionals who have previously worked within a Notified Body or Certification Assessment Body performing MDR/MDD conformity assessment activities.

Non-Negotiable Requirements

Applicants must:

✔ Have direct experience working for a Notified Body / Certification Body

✔ Have conducted Stage 2 and/or surveillance audits under MDR 2017/745, MDD 93/42, or ISO 13485

✔ Be able to provide a detailed audit log, including:

• Audit type (Stage 2 / Surveillance)
• Regulation/standard applied
• Applicable MDS/MDT codes
• Total man-days performed

For Technical Documentation Reviewers:

✔ Have completed a minimum of 5 full Technical File (FT/DT) assessments per relevant code within a Notified Body

✔ Be able to provide a detailed list of Technical File evaluations, including applicable MDA / MDN / MDS codes

Applications without documented Notified Body assessment experience will not be considered.

MDA Codes of Interest (Product Reviewer – Full List)

We are particularly seeking competence across the following MDA codes:

• MDA 0202 – Active non-implantable imaging devices utilising non-ionizing radiation
• MDA 0203 – Active non-implantable devices for monitoring of vital physiological parameters
• MDA 0204 – Other active non-implantable devices for monitoring and/or diagnosis
• MDA 0302 – Active non-implantable devices utilising non-ionizing radiation
• MDA 0303 – Active non-implantable devices utilising hyperthermia/hypothermia
• MDA 0305 – Active non-implantable devices for stimulation or inhibition
• MDA 0306 – Active non-implantable devices for extra-corporeal circulation, administration or removal of substances and haemapheresis
• MDA 0307 – Active non-implantable respiratory devices
• MDA 0308 – Active non-implantable devices for wound and skin care
• MDA 0312 – Other active non-implantable surgical devices
• MDA 0313 – Active non-implantable prostheses, devices for rehabilitation, patient positioning and transport
• MDA 0315 – Software
• MDA 0317 – Active non-implantable devices for cleaning, disinfection and sterilisation
• MDA 0318 – Other active non-implantable devices

Applicants should clearly indicate the specific MDA codes for which they hold documented Technical File assessment competence.

Minimum Professional Requirements

• University degree in medicine, pharmacy, engineering or other relevant sciences
• Minimum 4 years’ professional experience in healthcare products (manufacturing, audit, R&D or related activities)
• No consultancy involvement in device design, manufacturing, marketing, maintenance or QMS processes within the last 3 years (conflict of interest requirement)

Application Requirements

Please submit:

• Updated CV (Europass or equivalent, dated)
• Audit log (for Auditor applicants)
• Technical File assessment list (for Product Reviewers)
• Clearly stated MDA / MDN / MDS / MDT codes of competence

Extra information

Status

Open

Education Level

Secondary School

Location

United Kingdom

Type of Contract

Full-time jobs

Published at

17-02-2026

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English