Remote Regulatory Affairs contractor

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
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