Remote Regulatory Affairs contractor requires: • Bachelor's degree in engineering, life sciences, regulatory affairs, legal or a related field • 5-10 years+ of global medical device regulatory experience • Proven experience preparing, writing and submitting FDA 510k submissions (end to end) • Experience with ophthalmic devices, capital equipment, diagnostic devices, software in medical devices, cybersecurity • Strong working knowledge of: o FDA regulations (21 Parts 807, 820) o FDA guidance documents and eStar requirements o Experience with Canadian regulations, EU MDR (2017/745) including Class lla, Tech docs Annex ll/lll • Demonstrated ability to work independently as a contractor in a fast-paced environment • Experience filing medical device submissions in China and other countries • Experience with audiology devices • Experience with artificial-intelligence enabled devices o Strong technical writing and documentation skills o Ability to translate complex technical information into regulatory submissions o Detail-oriented with strong organization skills o Effective communicator across technical and non-technical stakeholders o Ability to manage multiple deliverables and timelines DUTIES: • FDA 510(k) submission o Conduct comprehensive review of technical documentation (design controls, V&V, risk, labeling, clinical evidence, and software as applicable) to ensure completeness, quality, and regulatory compliance o Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents) o Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format, o Lead submission lifecycle activities, including: o Acceptance Review support (RTA readiness) o Substantive Review coordination o Drafting and submission of responses to FDA requests for Additional Information, Interactive review communications o Updating submission content and modules as required o Interface cross-functionally to incorporate Business inputs and ensure alignment throughout the review process. o Provide regulatory leadership through FDA clearance. • EU MDR Technical Documentation Support o Conduct EU MDR readiness assessment aligned with Notified Body expectations and conformity assessment requirements. o Perform critical review and gap analysis of EU MDR technical file o Provide targeted recommendations to ensure audit-readiness and Notified Body acceptance o Lead or support submission to obtain CE Mark • Health Canada submission • Global Regulatory Strategy and Advisory •
Not specified in the original listing.
Not specified in the original listing.
Global Channel Management, Inc. specializes in managing and supporting channel partners and resources across various sectors. Focused on enhancing operational efficiencies and protective measures, the company aims to provide robust asset protection s... Read More