TÜV SÜD America Inc., a global leader in product safety and EMC testing, regulatory affairs and certification, has an immediate opening at our offices in the USA for a
Medical Device Auditor
The Medical Device Auditor, reporting to the MHS Manager, assesses non-active medical devices such as hip, knee, shoulder joint replacement, and spinal devices, as well as their manufacturers by utilizing the knowledge of the European Medical Devices Directives, other applicable regulatory requirements, and recognized standards such as ISO 13485 and ASTM standards.
The Medical Device Auditor performs regulatory audits of clients per European Medical Device Directives, Canadian Medical Device Regulations, Japanese Pharmaceutical Affairs Law and International quality system standards specifically ISO 13485, as well as internal Notified Body and TÜV SÜD America criteria. The auditor will conduct review to Quality System related tasks, such as management, design and development, corrective actions; as well as prepare reports and audit documentation for submission to the certification committee of the Notified Body.
The Medical Device Auditor performs evaluations of product regulatory submissions including: Design Dossiers (Class III) and Technical Files (Class II), according to European Medical Device Directives.
The minimum requirements include a Bachelor's degree in Mechanical Engineering or related field or equivalent; plus 1year of experience in medical device regulatory affairs, and a strong background with ISO 13485.
TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies.