Systems Regulation, ISO 14971, MDD 93/42/EEC, EU MDR, and other relevant international laws. Outstanding problem-solving...
required Experience in Schizophrenia or other psychiatric areas (e.g., bipolar, MDD) preferred Skills/Knowledge/Abilities...
(GMP), MDD, EU MDR, MDSAP, and ISO 13485 standards. As a Regulatory Compliance Specialist, you will play a vital role in... is a plus. Knowledge of FDA QSR, MDD, MDR, ISO 13485, and MDSAP preferred. Strong verbal and written communication skills...
with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR. Must demonstrate the ability to investigate...
(Japanese), Resolution RDC #59 (Brazil), TGA (Australia), EU MDR and MDD (European) requirements. Excellent communication...
requirements, including but not limited to, ISO 13485, CFR 820, MDSAP, MDD/MDR, and IVD/IVDR. The successful candidate...
specifications and other technical documents. Previous experience in EU MDD/IVDD or MDR/IVDR. Ability to work within a team...
and prediction Detailed understanding of IEC 62304, ISO 14971, IEC 60601, FDA and MDD design control requirements for medical...
, Change Notifications, and Submissions (including Documentary Audits under MDD/MDR) for regulatory agencies and distributors...
and/or other regulatory agencies. Experience reviewing design specifications and other technical documents. Previous experience in EU MDD...
resolution skills Specialized Knowledge: Knowledge of current FDA, ISO, MDD, and other related quality and regulatory system...
requirements. Prepare Technical Files /Design Dossier, Change Notifications, and Submissions (e.g. Documentary Audits under MDD...
MDD, and ISO 13485 requirements (Highly preferred) Be proficient in Microsoft Office, including: Word, Excel...
with FDA, Medical Device Single Audit Program (MDSAP), ISO13485, European Union Medical Device Directives (MDD), and In-Vitro...
803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC Excellent...
and EU Notified Bodies. Working knowledge of 510(k), MDD 93/42/EEC. Regulatory Affairs Certified RAC .(RAPS) Proficient...
compliance in accordance with FDA regulations, ISO13485, MDSAP, MDD/MDR and other applicable global regulatory requirements...
, ISO 14971, FDA and MDD In depth knowledge in at least one technical subject area: electrical, mechanical, software...
/authoring/obtaining approvals, including 510(k) premarket notifications, EU MDD/MDR Technical Files, and/or other documentation...