Union Medical Device Directive (MDD)/ Medical Device Regulation (MDR), and applicable guidance. Provide Quality... evolving priorities. Preferred: Solid understanding of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC...
and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP. Assist in the.... Experience with FDA 21 cfr 820, 21 cfr 11, 21 cfr 806, MDD, MDR, MDSAP, EN ISO 13485, EN ISO 14971, IEC 62366-1, EN ISO 15223...
(Australia, New Zealand, Korea, Taiwan, and Singapore), and EMEA. Strong working knowledge of EU (MDD / MDR) medical device...
Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC Communication proficiency; verbal and written. Problem Solving and Critical...
(Australia, New Zealand, Korea, Taiwan, and Singapore), and EMEA. Strong working knowledge of EU (MDD / MDR) medical device...
regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC Communication proficiency; verbal...
Disorder (MDD), Bipolar Disorder, Schizophrenia, Borderline Personality Disorder (BPD) and Substance Use Disorder (SUD...
range of diagnoses including MDD, anxiety disorders, OCD, SUD, and mood disorders. Clinicians are supported by a collegial supervision...
manufacturing compliance knowledge (GMPs) Medical device compliance (CFR, EU MDD/MDR, ISO, MDSAP) Experienced in leading GMP...
monitor) and by making periodic visual/audible checks when employees are performing work in a tank or confined space (MDD... as directed by ETM supervision. Responsibilities include but are not limited to: Meet all requirements of MDD-00209, (ETM...