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:
- 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
DUTIES:
- 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
- Health Canada submission
- Global Regulatory Strategy and Advisory
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