Job Title: Senior Regulatory Affairs Specialist (Medical Devices) Location: Remote Duration: Long term contract Job Description: -Subject Matter Expert for Class II and Class 510(K) submission. -Hands on experience with 510(k) authoring, submissions, and communicating with the FDA. -Hands on experience with software as a Medical Device (SaMD) and validation requirements and applicable consensus standards. Key Responsibilities: -Authoring US FDA 510(k) submission using eSTAR submission tool.
Job Title: CMC 2 Regulatory affairs Specialist Location: Remote Description: Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States Manage execution / authoring and review of CMC documentation (Module 1 , 2 and 3 / Part II ) for life cycle management - post-approval supplements, baseline dossiers, annual reports, registration renewals, response to health authority questions, assessment
Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for a remote based opportunity to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory submissions, collaborating with internal teams and stakeholders. Oversee external publishing coordination for IND/CTA submissions and related documents. Support document workf
