Senior Regulatory Affairs Specialist (Medical Devices)

Job Title: Senior Regulatory Affairs Specialist (Medical Devices)
Location: Remote
Duration: Long term contract

Job Description:
-Subject Matter Expert for Class II and Class III 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.
-Communication with FDA during the submission process including but not limited to pre-Sub, RTA, IR, AI
-Extracting and interpreting data from bench data, clinical trials, and other sources.
-Reviewing compliance with US FDA and applicable medical device consensus standards.
-Communication and collaboration with external client to meet predefined timelines.
Skill- Regulatory Affairs| Medical Devices, Publishing (Electronic submissions)