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