Regulatory Audit Specialist

Location: Andover MA or Remote
 Duration: 12 Months+ strong possibility to convert FT

 Experience: 15 years professional experience in the applicable role.  
 Education: Bachelor's /Master's degree in Computer Science, Quality Systems and/or Engineering. 
 
 Requirements: 
 Must be a very experienced and rigorous auditor. This role will be performing in-depth assessments (audits) of Design Projects that are currently in-development. 
Must have deep experience in efficiently performing detailed assessments of design control projects of products containing software against 21 CFR 820, ISO 13485, MDSAP, EUMDR, ISO 14971, ISO 62304, ISO 60601, ISO 62366 and others. 
Knowledge of clinical research as an input per EUMDR/MDD is helpful. 
Former assessors with FDA, CMDCAS, and/or NB encouraged to submit. 

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