Lead Auditor Medical Devices Regulations
Core
Conduct independent audits of medical device manufacturers and suppliers against MDR, ISO 13485, MDSAP, and UK MDR regulations, including on-site visits and desk research.
Role type
Lead Auditor (Medical Devices Regulations)
Builds
Compliance audit reports and improvement action plans for medical device companies
Domain
Medical Devices / Regulatory Compliance
Required skills
Medical Devices Regulation (MDR), ISO 13485, MDSAP, UKCA Mark, Quality Management Systems, Active Medical Devices manufacturing knowledge, Sterilization processes, Cleanroom production, Metal/Plastic/Chemical processing, Electronic components, Labeling and packaging
Preferred skills
Quality management in active medical device manufacturing, Product development/validation roles, MDCG guidance documents, Multiple medical device production technologies
Technologies
MDR, ISO 13485, MDSAP, UKCA Mark, MDCG guidance
Responsibilities
Perform independent audits against MDR, ISO 13485, MDSAP, and UK MDR; Conduct on-site inspections and document reviews; Translate audit findings into substantiated reports; Develop improvement action plans with clients; Report directly to Field Manager
Seniority
Senior, hands-on IC