Experience

Brosseau Consulting LLC
• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee
• President

  • Oct 2014 - Present

Oriel STAT A MATRIX
• United States
• Business Consulting and Services
• 1 - 100 Employee
• Affiliate

  • Jun 2019 - Present


Secure BioMed Evaluations

• United States
• Biotechnology
• 1 - 100 Employee

• Vice President - Quality and Regulatory Affairs

  • Jul 2016 - Feb 2018

  Quality Systems Management o 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 o Gap analysis of existing Quality Systems and orchestrate universal revisions to procedures for compliance to new/revised standards o Implement ISO 13485 quality system requirements and obtain ISO 13485 certification for new companies or… Show more Quality Systems Management o 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 o Gap analysis of existing Quality Systems and orchestrate universal revisions to procedures for compliance to new/revised standards o Implement ISO 13485 quality system requirements and obtain ISO 13485 certification for new companies or companies with only U.S. business o Serve as corporate representative for FDA inspections, ISO audits, and other regulatory audits o Perform mock audits to applicable regulations and standards to identify compliance concerns and areas for improvement o Fulfill Quality Management Representative responsibilities including the identification for areas of QMS improvement through implementation and structured evaluation of QMS metrics o Drive incorporation of ISO 14971 requirements throughout the QMS to ensure that all areas of the quality system are linked with risk evaluation and mitigation Regulatory Submissions and Approvals o Create and submit design dossiers and technical files for CE-Mark and European distribution o Manage 510(k) submissions and correspondence for timely FDA clearance of medical devices o 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. o 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 o Ongoing maintenance of Technical Files o Manage current regulatory library and ensure continued QMS compliance to new or revised regulation or standards

• Director of Regulatory Affairs and Quality Assurance

  • Jul 2015 - Jul 2016



CorMatrix Cardiovascular

• United States
• Medical Equipment Manufacturing

• Regulatory Affairs Manager

  • Jan 2014 - Jul 2015

  Roswell, Georgia



CryoLife, Inc.

• United States
• Biotechnology
• 1 - 100 Employee

• Regulatory Affairs and Field Assurance Manager

  • Mar 2001 - Dec 2013

  Kennesaw, Georgia Regulatory Affairs Responsibilities and Achievements: - Secure FDA approval or clearance of medical devices through submission of clear and thorough applications and successfully addressing requests for additional information - Obtain CE marking of medical devices through submission of accurate and compliant design dossiers for successful CE-marking review - Obtain approvals for medical devices and human tissues in various international markets including Japanese Shonin approval… Show more Regulatory Affairs Responsibilities and Achievements: - Secure FDA approval or clearance of medical devices through submission of clear and thorough applications and successfully addressing requests for additional information - Obtain CE marking of medical devices through submission of accurate and compliant design dossiers for successful CE-marking review - Obtain approvals for medical devices and human tissues in various international markets including Japanese Shonin approval and Foreign Manufacturer Accreditation for medical devices, Paul-Ehrlich-Institut approval for the distribution of human tissue preparations in Germany, and European Directorate for the Quality of Medicines (EDQM) Certificate of Suitability for materials of bovine origin for incorporation into medical devices 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 to include in-depth complaint investigations involving multiple departments, initiate corrective action is taken when required, and ensure compliant regulatory reporting for adverse events - Coordinate recalls of human tissue and medical devices - Perform internal departmental audits and maintain supplier quality files for critical suppliers - Conduct risk analyses according to ISO 14971 Other Responsibilities and Achievements: - Participation in due diligence process for corporate 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 Show less