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
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.
Location: Fremont, CA 94555 Mostly Remote Duration: 06 Months Contract (Possible Extension) Work location: The majority of the work is expected to be able to be performed remotely. On-site visits may be required on an ad-hoc basis, on same-day notice. Duties: The US Biopharma E&T (Engineering & Technology) Department is seeking a service partner to support revisions to our Facility and Engineering Drawings and Documentation database. These drawings are very critical to the site for design and
