21 CFR Part 820, MDD/EU MDR, ISO 13485, and ISO 14971. ◠Ability to travel approximately 10–20%. Preferred...
investigations. Lead internal and external audits (FDA, ISO, MDD). Oversee supplier quality activities including audits...
Bodies. Working knowledge of 510(k), MDD 93/42/EEC. Regulatory Affairs Certified RAC (RAPS). Proficient in using Microsoft...
. 3–5+ years of experience in Quality or Engineering roles. Detailed knowledge of FDA 21 CFR 820, GMP, MDD, EU-MDR, ISO...
Bodies. Working knowledge of 510(k), MDD 93/42/EEC. Regulatory Affairs Certified RAC (RAPS). Proficient in using Microsoft...
knowledge of FDA, ISO, and MDD quality systems applicable to medical device companies. Excellent written and verbal...
Bodies. Working knowledge of 510(k), MDD 93/42/EEC. Regulatory Affairs Certified RAC (RAPS). Proficient in using Microsoft...