Lead Auditor/Technical File Reviewer Freelance USA (MDR 2017/745)
Ente Certificazione Macchine, a European Notified Body No. 1282 for Regulation (EU) 2017/745 (MDR) and other European product directives. ECM is seeking qualified freelance professional based in the USA (preferably West Coast) for the combined role of Auditor and Technical File Reviewer (under Regulation (EU) 2017/745), who have gained significant experience in the same role(s) within other Notified Bodies.
Key Responsibilities
- Conduct audits at manufacturers and suppliers’ sites, in the USA and LATAM
- Codes of interest for the role of auditor: MDS1009, MDS1010, MDT2010
- Review technical documentation of assigned medical devices, assessing compliance with Regulation (EU) 2017/745
- Codes of interest for the role of Technical File Reviewer: MDA0202, MDA0203, MDA0204, MDA0302, MDA0303, MDA0305, MDA0306, MDA0307, MDA0308, MDA0312, MDA0313, MDA0315, MDA0317, MDA0318, MDS1009, MDS1010
- Manage certification procedures for an international portfolio of active medical device manufacturers
Mandatory Requirements
- University degree in relevant disciplines (e.g. medicine, pharmacy, engineering or other relevant sciences).
- The candidate has not offered or provided within the last three years, consultancy services in relation to the design, manufacturing, marketing, or maintenance of medical devices or regarding specific quality management system processes.
- Having carried out at least five Stage 2 or surveillance audits (according to MDR UE 2017/745, or MDD 93/42, or ISO13485) at another Notified Body or Certification Assessment Body, for a minimum of 8 man-days.
- Evaluation activities of at least 5 complete FT/DT (Technical Files) for each code at the Notified Body, in the role of Technical File Reviewer
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