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

Originally posted on Himalayas