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Advanced Clinical: Regulatory Affairs Specialist (Remote)

Advanced Clinical

This is a Contract position in Las Vegas, NV posted May 9, 2022.

Regulatory Affairs Specialist (Remote) RESPONSIBILITIES
· Writing FDA EUA and De Novo, Health Canada IO, EU CE Tech File, and other global registrations as requested
· Coordinating the accumulation of technical information and creates submissions for medical devices including in vitro diagnostics (IVDs) for approval, license, registration or clearance in any region.

· Performing CMC activities for assigned products for US, EU MDR/IVDR, Health Canada and rest of the world (ROW).

· Responsible for development of product launch strategy, including documenting testing requirements, submission pathways, and anticipated approval/clearance timelines for defined target markets.

· Interacting with the FDA, the EU Notified Body, and Health Canada; being updated on all country requirements and changes.

· Participating in change control meetings; reviewing and approvingrequests; notifying Regulatory Bodies of changes that impact clearances, licenses, etc.

· Performing labeling reviews/approvals as required.

· Researching and consolidating regulatory requirements to enable future development of regulatory strategies for all regions.

· Creating and maintaining registrations procedures/protocols.

· Working closely with internal and external customers to achieve success.

· Creating 510(k) submissions for Domestic Market (FDA).

Submit Q-Submission Meetings, such as pre-submission and issue meetings, to the FDA as needed.

· Creating Technical Files, Design Dossiers and Health Canada notifications of product changes for submission to the designated Regulatory Agency to obtain/maintain CE Marking.

· Reviewing and maintaining (MDD) Technical Files and Design Dossier/(MDR/IVDR) Technical Documentation after receiving CE Marking.

· Creating New License Submissions, Amendments, and Fax Back applications for Health Canada.

· Responding to questions from regulatory agencies during review/submissions.

· Supporting and assisting with the external audit program and participate in inspections and audits by Regulatory Bodies.

· Completing Regulatory Corrective and Preventive Actions generated from audit findings.

· Developing and maintaining policies and procedures regarding to regulatory submissions and processes.

· Creating and maintaining a foreign registration database of all current in country registrations and licenses.

· Partnering with International regulatory contacts to understand requirements for product registrations for new and modified products.

· Partnering with International regulatory contacts to plan, develop and submit product registration applications for new, modified products and/or registration renewals.

REQUIREMENTS
· Minimum five (5) industry experience in regulatory affairs capacity
· Experience authoring FDA EUA and De Novo, Health Canada IO, EU CE Tech File, and other global registrations
· Certificates, Licenses, Registrations: RAC certification is preferred.

· Knowledge and understanding of US, EU, Canada MDR/IVDR and international medical device regulations.

EDUCATION
· B.

A.

or B.S.

from four-year college university