Regulatory affairs Jobs in Miami, FL

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Senior Regulatory Affairs Specialist (Medical Devices)

ApTask

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Remote

Contract

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.
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Posted 5 days ago | Updated 4 days ago

Regulatory Affairs Specialist, Cell & Gene Therapy

Zachary Piper Solutions, LLC

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Remote

Full-time

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
Posted 4 hours ago

Regulatory Affairs Specialist I (DePuy Synthes) - Medical Device Business Services, Inc.

Johnson & Johnson

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Remote or Warsaw, Indiana, USA

Full-time

Description DePuy Synthes, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Regulatory Affairs Specialist I for the Joint Reconstruction team. This preferred location for this role is Warsaw, IN but candidates may also reside within a commutable distance of Leeds, UK . This role will work a Flex/Hybrid schedule with 3 days per week on-site, there is NO remote option. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in