🔎 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