Director, Regulatory Affairs – Regenerative Medicine & Biologics Quality
, including however not limited to: Regulatory Submissions (e.g., IND, BLA, & pre-RFD, 510(k), IDE, PMA, Technical Documentation...
, including however not limited to: Regulatory Submissions (e.g., IND, BLA, & pre-RFD, 510(k), IDE, PMA, Technical Documentation...
), Dynamic Application Security Testing (DAST), and IDE Plug-in environments using Veracode and Burp Suite. Design and implement... experience with SAST, DAST, and IDE plug-in integrations using tools such as Veracode and Burp Suite. Experience performing...
. Ability to program in Microsoft VS, other IDE, C# and C++, Phyton, Java, MATLAB is a Plus. Ability to read and interpret...
Technologies - XSD, XPath, XSLT, etc. Eclipse IDE Linux Knowledge of Agile Scrum methodology Knowledge of Atlassian Jira...
cycle Visual Studio Code or other IDE, including debugger tools Git or other versioning software Creating, maintaining...
investigations, including NSR or IDE studies and post-market clinical follow-up (PMCF) studies — taking personal accountability... phases is managed by Clinical Operations. Maintain current GCP certification and working knowledge of FDA IDE regulations...
AI-powered developer tools, such as Cursor IDE, Claude Code, or Windsurf. Experience with API testing. Web Technologies: Solid...
AI-powered developer tools, such as Cursor IDE, Claude Code, or Windsurf. Experience with API testing. Web Technologies: Solid...
AI-powered developer tools, such as Cursor IDE, Claude Code, or Windsurf. Experience with API testing. Web Technologies: Solid...
cycle Visual Studio Code or other IDE, including debugger tools Git or other versioning software Creating, maintaining...