Research Compliance Coordinator III
, exempt and expedited categories, and other regulatory determinations (e.g. subpart determinations, IDE/IND determinations...
, exempt and expedited categories, and other regulatory determinations (e.g. subpart determinations, IDE/IND determinations...
management tools (e.g. GIT, Trac, or Subversion) - Python, Eclipse IDE - Google Protocol Buffer, - Model-based design (e.g...
stakeholders (Public Relations, Marketing, Public Policy, IDE, Global Executive Relationship team, etc.) to create and distribute...
, design, materials and manufacturing for impact to US and EU requirements RAC Certification Experience with 510(k)/IDE/PMA...
Application Server; Eclipse IDE; Server-side application frameworks, including JSP, Servlet and Spring; ORMs, including Hibernate...
-Submission and IDE submissions, and ensures timely regulatory filings and documentation processes including technical files.... Key Responsibilities and Duties Prepare 510(k)s, letters/justifications to file, Investigational Device Exemption (IDE...
Cultural Awareness Day in support of IDE On-site medical/wellness center (Worcester only) Click here for the full EEO...
to ensure compliance with federal regulations, GCP, and IND/IDE. Work closely with various departments to ensure adherence... of human subjects clinical research. In-depth knowledge of federal regulations, GCP, and IND/IDE in both adult and pediatric...
applications; Relational database usage with commercial-grade databases; Developing applications using Eclipse or similar IDE...
, and ability to use them to best effect Ability to use tools (such as IDE, debugger, build tools, source control, ServiceNow instances...