Synergybioscience
Senior Regulatory Affairs Consultant
Synergybioscience, Dallas, Texas, United States, 75215
Job Summary
This is a highly visible role and will require extensive interaction with upper management as well as regulatory bodies. Main Duties: Successful Global Regulatory Submissions and Approvals, including 510(k)s and Technical Documentation Review by Notified Body in EU. Prepared product registrations for various countries and/or provided additional information to regulatory bodies for successful registration of products. Reviewed design and labeling changes to assess regulatory impact, filed various submissions and updates with regulatory agencies. Maintained up-to-date regulatory requirements for the business unit (Registrations/Regulatory Audits/Quality Manual/Quality System Certificates). Prepared and submitted 510(k)'s, IDEs, and other applicable product submissions according to FDA guidelines. Job Responsibility: Regulatory specialist with proven ability in presenting, developing, and implementing pre and post-market regulatory strategies for medical device submissions for US and OUS. Interface with regulatory authorities representing the organization. Responsible for regulatory review of new supplier & part qualifications. Supported submissions to EU and FDA. Authored and implemented a Regulatory Compliance Plan for New Product Development. Lead site readiness efforts prior to FDA, TUV/ISO, and vendor audits and war room. Interfaced with auditors for reviews and retrievals. Responded to all audit questions and post requests from regulatory agencies. Post-market surveillance report for annual submission. Led development and preparation of SOPs. Leading reviews and response management for submissions for approvals by working with cross-functional members. Leading labeling remediation project incorporating FDA/OUS guidance & harmonized standards. This also includes UD. Other Skills: Extensive experience as a direct correspondent to negotiate and build relationships with FDA, EU Notified Bodies, Health Canada, marketing, quality, and engineering. Working knowledge of FDA regulations and EU Directives is advantageous for preparing successful regulatory submissions and maintaining regulatory compliance throughout the product lifecycle. Experience in preparing and submitting regulatory submissions (510K, IDE, PMA, and EU technical file). Prepared U.S. regulatory submissions necessary for new product market clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements. Job Type:
Contract
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This is a highly visible role and will require extensive interaction with upper management as well as regulatory bodies. Main Duties: Successful Global Regulatory Submissions and Approvals, including 510(k)s and Technical Documentation Review by Notified Body in EU. Prepared product registrations for various countries and/or provided additional information to regulatory bodies for successful registration of products. Reviewed design and labeling changes to assess regulatory impact, filed various submissions and updates with regulatory agencies. Maintained up-to-date regulatory requirements for the business unit (Registrations/Regulatory Audits/Quality Manual/Quality System Certificates). Prepared and submitted 510(k)'s, IDEs, and other applicable product submissions according to FDA guidelines. Job Responsibility: Regulatory specialist with proven ability in presenting, developing, and implementing pre and post-market regulatory strategies for medical device submissions for US and OUS. Interface with regulatory authorities representing the organization. Responsible for regulatory review of new supplier & part qualifications. Supported submissions to EU and FDA. Authored and implemented a Regulatory Compliance Plan for New Product Development. Lead site readiness efforts prior to FDA, TUV/ISO, and vendor audits and war room. Interfaced with auditors for reviews and retrievals. Responded to all audit questions and post requests from regulatory agencies. Post-market surveillance report for annual submission. Led development and preparation of SOPs. Leading reviews and response management for submissions for approvals by working with cross-functional members. Leading labeling remediation project incorporating FDA/OUS guidance & harmonized standards. This also includes UD. Other Skills: Extensive experience as a direct correspondent to negotiate and build relationships with FDA, EU Notified Bodies, Health Canada, marketing, quality, and engineering. Working knowledge of FDA regulations and EU Directives is advantageous for preparing successful regulatory submissions and maintaining regulatory compliance throughout the product lifecycle. Experience in preparing and submitting regulatory submissions (510K, IDE, PMA, and EU technical file). Prepared U.S. regulatory submissions necessary for new product market clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements. Job Type:
Contract
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