FDA 510(k) submission
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
Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents)
Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format,
Lead submission lifecycle activities, including: Acceptance Review support (RTA readiness)
Substantive Review coordination
Drafting and submission of responses to FDA requests for Additional Information, Interactive review communications
Updating submission content and modules as required
Interface cross-functionally to incorporate Business inputs and ensure alignment throughout the review process.
Provide regulatory leadership through FDA clearance.
EU MDR Technical Documentation Support
Conduct EU MDR readiness assessment aligned with Notified Body expectations and conformity assessment requirements.
Perform critical review and gap analysis of EU MDR technical file
Provide targeted recommendations to ensure audit-readiness and Notified Body acceptance
Lead or support submission to obtain CE Mark.

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: FDA regulations (21 Parts 807, 820) FDA guidance documents and eStar requirements
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
Strong technical writing and documentation skills
Ability to translate complex technical information into regulatory submissions
Detail-oriented with strong organization skills
Effective communicator across technical and non-technical stakeholders
Ability to manage multiple deliverables and timelines.

Regulatory Affairs Contractor

Key skills