Job Title

Freelance MDR Lead Auditor / Technical Documentation ReviewerEU Regulation 2017/745 (MDR) – Notified Body Experience EssentialECM is seeking experienced freelance professionals for:Lead Auditor (MDR 2017/745)Technical Documentation Reviewer / Product Assessoror a combined Auditor & Technical Reviewer roleThis 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 RequirementsApplicants must:Have direct experience working for a Notified Body / Certification BodyHave conducted Stage 2 and/or surveillance audits under MDR 2017/745, MDD 93/42, or ISO 13485Be able to provide a detailed audit log, including:Audit type (Stage 2 / Surveillance)Regulation/standard appliedApplicable MDS/MDT codesTotal man-days performedFor Technical Documentation Reviewers:Have completed a minimum of 5 full Technical File (FT/DT) assessments per relevant code within a Notified BodyBe able to provide a detailed list of Technical File evaluations, including applicable MDA / MDN / MDS codesApplications 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 radiationMDA 0203 – Active non-implantable devices for monitoring of vital physiological parametersMDA 0204 – Other active non-implantable devices for monitoring and/or diagnosisMDA 0302 – Active non-implantable devices utilising non-ionizing radiationMDA 0303 – Active non-implantable devices utilising hyperthermia/hypothermiaMDA 0305 – Active non-implantable devices for stimulation or inhibitionMDA 0306 – Active non-implantable devices for extra-corporeal circulation, administration or removal of substances and haemapheresisMDA 0307 – Active non-implantable respiratory devicesMDA 0308 – Active non-implantable devices for wound and skin careMDA 0312 – Other active non-implantable surgical devicesMDA 0313 – Active non-implantable prostheses, devices for rehabilitation, patient positioning and transportMDA 0315 – SoftwareMDA 0317 – Active non-implantable devices for cleaning, disinfection and sterilisationMDA 0318 – Other active non-implantable devicesApplicants should clearly indicate the specific MDA codes for which they hold documented Technical File assessment competence.Minimum Professional RequirementsUniversity degree in medicine, pharmacy, engineering or other relevant sciencesMinimum 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 RequirementsPlease 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