of GMP, ISO 13485 & MDD requirements. #LinkedIn Remote Requisition ID: 599879 The anticipated annualized base amount...
, MDSAP, MDD and MDR standards. The Sr. Medical Device Auditor is responsible to make relevant decisions concerning the audit... such as MDSAP, MDD, MDR and EU. In performing the duties described above, to ensure that such duties are performed in an efficient...
the product lifecycle. Develop MDD and MDR design dossiers, technical files and change notifications and Design History...: MDD/MDR design dossiers, technical files and change notifications, and Design History Files for Class I, II and III...
under MDD/ MDR) for both regulatory agencies and distributors. Creates, reviews and approves change requests. Assist...
of comprehensive design verification and process validation protocols GMP/ISO/MDD: Interprets GMP, MDD, and ISO regulations...
verification and process validation protocols GMP/ISO/MDD: Interprets GMP, MDD, and ISO regulations into Company and product...
), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/ Medical Device Regulation (MDR... Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304, FDA's General Principles...
and 804 (MDR regulations), ISO 13485, ISO 14971, and MDD 93/42/EE. 4. Ability to execute established procedures and protocols...
for handling equipment (FDA 510, ISO 13485, MDD). Follow Lean Manufacturing principles, including waste reduction and 5S...
such as QSRs, FDA, ISO, MDD and other applicable regulations. Experience and understanding Process Validations (IQ, OQ, PQ), 6S...