: Ensure all design and development activities adhere to applicable regulatory requirements (e.g., FDA, ISO 13485, MDD/MDR...
resolution skills Specialized Knowledge: o Knowledge of current FDA, ISO, MDD, and other related quality and regulatory system...
ability to develop solutions for problems that require the regular use of creativity Knowledge of ISO, FDA, MDD and regulations...
tasks and meet deadlines. Experience working under regulated quality systems such as cGMP’s, ISO, and the MDD...
deadlines. Experience working under regulated quality systems such as cGMP’s, ISO, and the MDD is a plus Familiarity...
deadlines. Experience working under regulated quality systems such as cGMP’s, ISO, and the MDD is a plus Familiarity...
deadlines. Experience working under regulated quality systems such as cGMP’s, ISO, and the MDD is a plus Familiarity...
tasks and meet deadlines. Experience working under regulated quality systems such as cGMP’s, ISO, and the MDD...
of MDD (Medical Device Directive), EU-MDR (Medical Device Regulations), ISO 13485 (Quality Management Systems...
regulations and standards. Improves and maintains the quality system in line with ISO 13485, Medical Device Directive (MDD...
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...
regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC Communication proficiency; verbal...
(Australia, New Zealand, Korea, Taiwan, and Singapore), and EMEA. Strong working knowledge of EU (MDD / MDR) medical device...
treats a variety of diagnoses such as Major Depressive Disorder (MDD), Bipolar Disorder, Schizophrenia, Borderline...
manufacturing compliance knowledge (GMPs) Medical device compliance (CFR, EU MDD/MDR, ISO, MDSAP) Experienced in leading GMP...
range of diagnoses including MDD, anxiety disorders, OCD, SUD, and mood disorders. Clinicians are supported by a collegial supervision...
. Knowledge & Skills Excellent working knowledge of FDA Code of Federal Regulations (21CFR), ISO 13485, MDD/MDR regulations...
of regulatory expectations and industry practices including industry standards QSR, ISO13485, and MDD. Other Skills and Abilities...