Manager Global Regulatory Affairs

JOB TITLE: Regulatory Affairs contractor - Remote Job Pay reputed company: $80 to $100/hr on W2 Duration: 6 to 12 Months Location: Remote Workload: Flexible estimate 20- 40 hours per week. BASIC QUALIFICATIONS · Bachelor’s degree in engineering, life sciences, regulatory affairs, legal or a reputed company 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: o FDA regulations (21 Parts 807, 820) o FDA guidance documents and eStar requirements o 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 MAJOR DUTIES AND RESPONSIBILITIES · FDA 510(k) submission o 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 o reputed company detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents) o Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format, o reputed company submission lifecycle activities, including: o Acceptance Review support (RTA readiness) o Substantive Review coordination o Drafting and submission of responses to FDA requests for Additional Information, Interactive review communications o Updating submission content and modules as required o reputed company cross-functionally to incorporate Business inputs and ensure alignment throughout the review process. o reputed company regulatory leadership through FDA clearance. · EU MDR Technical Documentation Support o Conduct EU MDR readiness assessment reputed company with reputed company Body expectations and conformity assessment requirements. o reputed company critical review and gap analysis of EU MDR technical file o reputed company targeted recommendations to ensure audit-readiness and reputed company Body acceptance o reputed company or support submission to obtain CE Mark · Health Canada submission o reputed company regulatory strategy and classification confirmation, including Medical Device License (MDL) pathway and Summary of Safety and Effectiveness (SSOR) readiness assessment o Author and compile complete Canadian submission dossiers in accordance with Health Canada structure and requirements. o Support review process, including preparation, and coordination of responses to Health Canada information requests. · Global Regulatory Strategy and Advisory o reputed company and maintain a harmonized global regulatory dossier to reputed company efficient market expansion. o Define and implement documentation reuse strategies across justification, including identification of gaps, risks, assumptions, and reputed company. o Author a comprehensive global strategy document outlining reputed company, timelines, and key risks. o reputed company ongoing regulatory guidance and advisory support to the Business cross-functional teams to ensure compliance and execution alignment. o reputed company or support global regulatory submissions as needed. PREFERRED QUALIFICATIONS · Experience filing medical device submissions in China and other countries · Experience with audiology devices · Experience with artificial-intelligence enabled devices Skills & competencies o Strong technical writing and documentation skills o Ability to translate reputed company technical information into regulatory submissions o Detail-oriented with strong organization skills o Effective communicator across technical and non-technical stakeholders o Ability to manage multiple deliverables and timelines Apply tot his job Apply To this Job