Remote Regulatory Affairs contractor

Remote Regulatory Affairs contractor requires:

• Bachelors 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