We are looking for a reliable, detail oriented, hard working candidate with the desire to develop and continually improve. If being a part of an inn ... more
Knowledge required:
•Computer Literate in a Windows environment (Word, Excel, Access, Outlook, etc.)
•FDA premarket notification procedures.
•FDA GMP regulations.
•Strong knowledge of regulatory requirements for medical devices and their manufacturing controls
•Knowledge of electrical and mechanical Quality Control inspection techniques
•Proficiency with ISO and FDA GMP regulations, concepts, procedures
Skills required:
•Strong math and analytical skills, ability to read Engineering drawings
•Strong troubleshooting/diagnostic skills
•Strong communication, interpersonal, and technical writing skills
•Deadline-oriented time management and organizational skills
•Skilled in writing and developing SOPs, specifications and guidelines
Education/Training/Experience:
Minimum 5 years’ experience in RA in a Medical Device Environment with several 510(k) product submissions. Knowledge/experience of combination products. Bachelor’s Degree or better in Engineering or related technical field, or a comparable combination of education and experience. RAC or comparable regulatory certification preferred
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Ready to Take Ownership of your Career? Apply Now!
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