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:
• • 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