Bryan Brosseau

Bryan Brosseau

Bio

Mr. Brosseau’s experience has been forged in over 15 years in the medical device and biologics industries under challenging circumstances and tight deadlines. With a varied and in-depth knowledge of quality and regulatory requirements, Bryan is able to hone in on the necessary requirements of a project to ensure quality and compliance without impeding progress. With numerous domestic and international regulatory approvals for medical devices and biologics, his thorough understanding of the regulatory maze means a clear roadmap for your regulatory success.

Bryan’s creative solutions have been effective in resolving FDA 483s and warning letters, addressing compliance and operations challenges, creating compliant and convincing technical marketing material, and getting medical devices and biologics to market quickly. Bryan received his Bachelor’s Degree in Biology from the University of Georgia and maintains a Regulatory Affairs Certification (US) from the Regulatory Affairs Professionals Society. Prior to joining SBME in 2015, Bryan served in various Operations, Quality, and Regulatory roles at several medical device and biologics companies.

Services

Bryan’s primary areas of expertise include regulatory submissions, regulatory compliance, quality systems management and technical support. Bryan also provides project management support and excels at both discrete technical activities and high-level management due to his extensive experience in the medical device and biologics industries. With a varied and in-depth knowledge of quality and regulatory requirements, Bryan will ensure a timely path to market, the highest standard of quality, and regulatory compliance for your company.

Regulatory Submissions
  • FDA approval and clearance of medical devices
  • CE marking of medical devices
  • Approvals for medical devices in various international markets including Japanese
  • Shonin approval and Foreign Manufacturer Accreditation for medical devices
  • Authorization for human tissue distribution in various international markets including Paul-Ehrlich-Institut approval in Germany
  • Obtain European Directorate for the Quality of Medicines (EDQM) Certificate of Suitability for materials of bovine origin for incorporation into medical devices
  • Successfully represent numerous companies during audits performed by FDA, EU
  • Notified Bodies, and various state and international regulatory agencies
  • Author and maintain Clinical Evaluation Reports for obtaining and renewing CE certification
  • Provide regulatory oversight for clinical trials
  • Review marketing materials for regulatory compliance and author compliant and effective marketing materials
Quality System Management
  • Full Quality System Management including: Document Control, Record Control, Quality Planning and Completion of Quality Objectives, Quality Management
  • Representation, Training, Risk Management, Design Control, Labeling Control and Review, Internal Audits, Supplier Management and Auditing, Corrective and Preventive Action, Complaint Investigation and Adverse Event Reporting, Field Action (Recalls), NCR Investigation and Resolution, and Product and Process Controls
  • Drive Quality System performance and continual improvement through the establishment and ongoing evaluation of quality metrics
  • Maintain licenses and perform related periodic reporting
Due Diligence and Project Management
  • Perform Quality and Regulatory aspects of due diligence for product and company acquisitions and report findings via a risk/benefit approach
  • Manage development projects to ensure regulatory compliance and adherence to desired timelines
  • Assemble and manage project teams to ensure the highest quality of work and most efficient development
Experience in the Following Therapy Areas
  • Heart Valves, Cardiac Reconstructive Devices, Vascular Grafts, Dialysis Access
  • Devices, Surgical Laser Consoles and Delivery Systems, Allograft Tissues, Xenograft Tissues, Surgical Adhesives, Electronic Medical Devices, Orthopedic and Spinal Implants and Instrumentation, Hemostatic Agents, Hydrogels, Surgical Meshes, and Cosmetic Devices
July 2015 – Present: Secure BioMed Evaluations
Vice President – Quality and Regulatory Affairs
  • Quality Systems Management
    • Implementation and management of Quality Systems for Medical Device and Biologics companies for compliance with 21 CFR 820, ISO 13485, EU Medical Device Directive, Canadian Medical Device Regulations, and AATB Standards
    • Perform gap analysis of existing Quality Systems and orchestrate universal revisions to procedures for compliance to new or revised standards
    • Implement ISO 13485 quality system requirements and obtain ISO 13485 certification for new companies and companies with only domestic business
    • Serve as the lead corporate representative for FDA inspections and ISO audits
    • Perform mock audits to applicable regulations and standards to identify compliance concerns and areas for improvement
    • Fulfill Quality Management Representative responsibilities including the identification for areas of QMS improvement through implementation and structured evaluation of QMS metrics
    • Drive incorporation of ISO 14971 requirements throughout the quality system to ensure that all areas of the quality system are linked with risk evaluation and mitigation
  • Regulatory Submissions and Approval
    • Create and maintain design dossiers and technical files for CE-Mark and European distribution
    • Complete and maintain major elements of design documentation required for continued MDD compliance including, but not limited to, Clinical Evaluation Reports, Post-Marketing Clinical Follow-Up, Master Verification and Validation Reports, and Product Labeling.
    • Review, generation, and revision of complaint and effective marketing literature to ensure desired marketing claims and product representation are maximized while remaining within the bounds of regulatory approval and product validation.
  • Regulatory Compliance
    • Complete revision and maintenance of Technical Files including new Clinical Evaluation Reports
January 2014 – July 2015: CorMatrix Cardiovascular, Inc.
Regulatory Affairs Manager
  • Regulatory Approvals and Licensing
    • 510(k) Clearance for CorMatrix CanGaroo ECM Envelope and CorMatrix ECM for Vascular Repair
    • Registration and approval of CorMatrix products in Australia, Western Europe, Latin America, and Middle East
    • Obtain notified body approval for device and labeling changes for CE-marked products and coordinate Notified Body transfer
  • Regulatory Compliance
    • Complete revision and maintenance of Technical Files including new Clinical Evaluation Reports
    • Create master reports to document product performance and compliance to harmonized standards
    • Regulatory representative and independent reviewer on development teams including role as independent reviewer for a novel electrical injection system for a particulate ECM product
    • Successful third party inspections including Notified Body assessments, Australia Therapeutic Goods Administration audit, and due diligence assessments
    • Develop and maintain Standard Operating Procedures in compliance with domestic and international regulatory requirements including team development of new design control and risk management procedures
    • Participate in all aspects of complaint handling to ensure compliant investigation, reporting, and corrective action, when required
    • Review promotional materials for regulatory compliance and provide compliant and effective alternatives to unacceptable materials
August 2004 – December 2013: CryoLife, Inc., Regulatory Affairs
  • October 2010 – December 2013: Regulatory Affairs and Field Assurance Manager
  • October 2007 – October 2010: Field Assurance Manager and Regulatory Affairs Specialist
  • March 2006 – October 2007: Field Assurance Supervisor
  • June 2005 – March 2006: Field Action Coordinator
  • August 2004 – June 2005: Field Assurance Associate
Regulatory Affairs Responsibilities and Achievements
  • SecureFDA approval or clearance of medical devices including surgical mesh, transmyocardial laser revascularization devices, and surgical hemostatic agents.
    • Achieve approval or clearance through creation of clear and thorough submissions for device approval/clearance and successfully addressing requests for additional information
    • Obtain timely FDA approval or clearance of changes to device design, manufacturing, and labeling
    • Compliant annual PMA reporting and registration/listing for corporate subsidiaries and associated products
  • ObtainCE marking of medical devices including surgical mesh, transmyocardial laser revascularization devices, and surgical hemostatic agents.
    • Author design dossiers for successful CE-marking review
    • Maintain technical files and effective communication with Notified Body regarding device changes to ensure timely approval of changes
    • Ensure compliance of medical devices to harmonized standards and other international standards (ISO, IEC, EN) through internal evaluations or coordination of third-party testing
  • Obtain approvals for medical devices and human tissues in various international markets
    • Japanese Shonin approval and Foreign Manufacturer Accreditation for medical devices
    • Paul-Ehrlich-Institut approval for the distribution of human tissue preparations in Germany
    • European Directorate for the Quality of Medicines (EDQM) Certificate of Suitability for materials of bovine origin for incorporation into medical devices
  • Ensure corporate awareness of and compliance to regulatory requirements
    • Periodic review of regulatory changes and corporate dissemination of relevant information
    • Inform upper management of quality systems metrics according to ISO 13485 through periodic Quality Management Reviews
  • Primary leader and contributor in project teams during product development
    • Develop regulatory strategy and provide regulatory guidance
    • Participation in risk analyses conducted according to ISO 14971
    • Ensure labeling meets FDA regulation and requirements outlined in EN 980, EN 1041, and ISO 15223.
    • Review of promotional materials for regulatory compliance
    • Oversee regulatory requirements for human tissue processing and distribution
    • Maintain federal and state tissue bank licenses and registrations and complete tissue banking annual reports
    • Successfully address FDA inquiries related to human tissue adverse event reports, HCT/P deviation reports, and FDA Tissue Reference Group requests
    • Lead gap analyses for new or revised regulations and standards
Field Assurance and Quality Assurance Responsibilities and Achievements
  • Successfully represent company during audits performed by FDA, Notified Body, and various state and international regulatory agencies
  • Manage domestic and international complaint handling for human tissue and medical devices
    • Coordinate in-depth complaint investigations involving multiple departments
    • Ensure that appropriate corrective action is taken when required in response to complaint investigations
    • Manage all regulatory reporting and associated correspondence for adverse events
  • Coordinate recalls of human tissue and medical devices
  • Perform internal departmental audits and maintain supplier quality files for critical suppliers
Other Responsibilities and Achievements
  • Participation in due diligence process for acquisitions and incorporate new product lines after acquisition
  • Regulatory Affairs Certification (United States)
  • Subject matter expert, presenter, and company representative for Regulatory Affairs Professionals Society and American Association of Tissue Banks
March 2001 – August 2004: CryoLife, Inc., Tissue Processing Laboratory
  • May 2003 – August 2004: Team Leader
  • March 2001 – May 2003: Dissector I – III
  • Oversee daily operations of the tissue processing laboratory
    • Assign tissue dissections, tissue processing, and other laboratory tasks to technicians
    • Ensure all processing timelines were met
    • Ensure all shift duties complete prior to shift change
  • Serve as Safety and Compliance Officer for tissue processing laboratory
  • Dissection and processing of all tissue types
  • Bachelor’s Degree, Biology, University of Georgia
  • Regulatory Affairs Certification (US), Regulatory Affairs Professionals Society
Bryan Brosseau

7828 Hickory Flat Highway, Suite 120, Woodstock, GA 30188

(770) 837-2681

800-361-0945

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