and practical implementation of FDA, ISO, MDD regulations within the medical device industry Demonstrated proficiency in project...
Bodies Working knowledge of 510(k), MDD 93/42/EEC Regulatory Affairs Certified RAC (RAPS) Proficient in using Microsoft...
including FDA QSR, ISO 13485, and EU MDD. MAJOR DUTIES AND RESPONSIBILITIES: Serves as Management Representative Hosts FDA... 13485, and EU MDD requirements Routinely evaluates the existing quality system to identify opportunities to streamline...
-1:9, our unit treats a variety of diagnoses such as Major Depressive Disorder (MDD), Bipolar Disorder, Schizophrenia...
for major depressive disorder (MDD) scheduled for Q1 2026. This individual will play a pivotal role in ensuring providers... Reimbursement Manager will serve as the primary point of contact for providers on reimbursement matters related to the new MDD...
, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, and Medical Device Directives (MDD...
preferred Working knowledge of FDA/ISO/MDD Quality systems for medical device companies. Excellent written and oral...
62304, ISO 14971, IEC 82304-1, MDD, and FDA QSR. Experience developing mechatronic products with IEC 60601...
21 CFR Part 820, MDD/EU MDR, ISO 13485, and ISO 14971. â— Ability to travel approximately 10-20%. Preferred...
investigations. Lead internal and external audits (FDA, ISO, MDD). Oversee supplier quality activities including audits...