MDR Lead Auditor
hace 2 días
London
🔎 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 🚫 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 ✔ 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