Tara Burnett

Experience

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  Daavlin

  Jul 2003 - May 2009

  Regulatory Affairs Manager

  Responsible for the design and implementation of policies and procedures to ensure that quality standards are met company wide. Oversee testing of processes and products.Responsible for preparing and implementing internal and supplier auditsResponsible for regulatory compliance to the following standards: ISO13485:2003, FDA 21 CFR Part 20, and the European Union Medical Device Directive 93/42/EEC.Responsible for FDA Audits, creating and filing 510K’s, creating and submitting Technical Files for CE, creating and submitting Canadian License ApplicationsCreated and submitted the successfully approved 510(k)’s for Class II Medical DevicesCreated and submitted the successfully approved Technical Files for Class IIa Medical Devices for CE approvalCreated and submitted the successfully approved Health Canada Medical Device License for Class II Medical DevicesResponsible for working directly with the ISO Auditor, FDA Auditor, and CE Auditor, and EMC and Safety Testing Engineers regarding all compliance issues, testing, and audits.Responsible for handing Customer Complaints, Inquiries, MDR’s, Recalls, and CAPA’sResponsible for reporting to Top Management all trends, resource needs, CAPA’s, Customer Complaints, Supplier Trends, Audit Results, Customer Feedback, Recalls, QMS Changes, Non-conforming Product, Training, New or Revised Regulatory Requirements, Quality Policy, and Quality Objectives, and Improvement Recommendations Show less

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  Consultant in Regulatory Affairs

  May 2007 - Dec 2021

  Consultant

  Provide consulting and internal auditing services to Medical Device Manufacturers on the requirements for FDA, ISO, and Customer required compliance.

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  Baxter International Inc.

  May 2009 - Feb 2013

  Regulatory Affairs Manager

  Responsible for the design and implementation of policies and procedures to ensure that quality standards are met company wide. Responsible for preparing and implementing supplier audits, and managing the internal audit programResponsible for regulatory compliance to the following standards: ISO13485:2003, FDA 21 CFR Part 20, Japanese PAL and the European Union Medical Device Directive 93/42/EEC.Responsible for FDA Audits, creating and filing 510K’s, creating and submitting Technical Files for CE, creating and submitting Canadian License ApplicationsCreated and submitted the successfully approved Health Canada Medical Device License for Class II Medical DevicesResponsible for working directly with the ISO Auditor, FDA Auditor, and CE Auditor, and EMC and Safety Testing Engineers regarding all compliance issues, testing, and audits.Responsible for handing Recalls.Responsible for reporting to Top Management, Resource needs, Audit Results, Recalls, QMS Changes, Training, New or Revised Regulatory Requirements, and Recommendations for Improvement Responsible for working with product development to ensure that all product design projects are regulatory compliant. Show less

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  Baxter Healthcare

  Feb 2013 - Sept 2013

  Senior Manager, Regulatory Affairs

  Initiate, manage and maintain operational activities in support of new and existing marketing authorizations.Plan and manage complex projects and prioritize workload.Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards.Maintain appropriate communication within the RA function, SBU marketing, and other functions primarily at the project team level.Communicate proactively and report to regulatory authorities.Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks.Assess impact of new regulations and provide feedback.Set team, group, or service objectives to assure they align with the Regulatory strategy.Provide technical and strategic input for regulatory decisions. Manage budget at country level.Provide direct supervision of individuals including mentoring, performance management and staffing decisions. Show less

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  Midmark Corporation

  Sept 2013 - Aug 2015

  Dir of Quality and Regulatory

  • Responsible for the implementation and maintenance of Quality Systems for Midmark in compliance with US Food and Drug Administration, Health Canada, EU and other applicable international requirement.• Responsible for leading the strategic and operational aspects of Midmark’s regulatory program. • Responsible for the Quality Control and Quality Assurance functions and ensure compliance to corporate policies, US FDA, other applicable federal/state agency and international requirements, as appropriate. • Responsible for leading the preparation and submission of regulatory documents in the US and other countries for approval at various stages of the development process. Show less

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  Colorado State University

  May 2014 - Jul 2014

  Instructor, Regulatory Affairs Certificate Program

  Instructor for the Colorado State University School of BioEngineering's Regulatory Certificate Program course, EGLL 4094: FDA Quality System Regulation (21 CFR 820) and ISO 13485:2003 for Medical Devices. Provided my professional end educational experience to the student to allow them to learn about the FDA’s Quality System Regulations (QSR) as they apply to the requirements and manufacturing quality of nationally and internationally commercialized products with a specific focus on the practice and implementation of a compliant Quality System. Show less

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  SensoryEffects

  Dec 2015 - Jul 2017

  Quality Assurance Manager

  Define and maintain the programs and procedures necessary to maintain an acceptable level of product quality and customer satisfaction as established by various federal, state, customer and company standards.-Manage Microbiology and plant laboratories. -Assure procedures are followed by maintaining written SOPs and by regular reviews of the documented results.-Manage all regulatory inspections including corrective actions. -Consult with production personnel to ensure that product and operating conditions meet state and federal inspection standards. -Assure all product specifications are met. A system of hold and release is established and maintained by the QA Manager. -Assist and set up all customer inspections. -Verify and investigate all customer complaints with production.-Oversee the corporate Quality System including SQF and HACCP. Reports to upper management monthly on the status of the programs. -Conduct and/or manage internal audits on a regular basis to determine if quality systems are being maintained and followed. - Certified as SQF Practitioner.-Work with the Operations Manager to assure compliance. -Oversee the rabbinical requirements for the Orthodox Union, organic program through QAI and the Halal certification program through IFANCA and prepares all necessary documentation for ingredients and finished products to assure compliance with said requirements. Show less

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  TekniPlex

  Jul 2017 - Dec 2021

  Director of Quality

  • Establish and maintain a consistent global quality approach, by sharing best practices and root cause/corrective actions to customer issues. • Plans, directs, and coordinates quality activities to ensure that goals and objectives of product performance are accomplished and represents US Films business to customers. • Assure consistent quality of production by developing and enforcing good manufacturing practice (GMP) systems, validating processes, providing documentation and managing staff. • Act as a business leader, working with sales, marketing, operations, supply chain, and other functions to meet or exceed budget sales and EBITDA objectives while focusing on quality and safety. • Develop and maintain a quality management system including quality manuals and all required documentation necessary to meet the requirements of ISO 15378 and ISO 13485. • Lead validation processes using statistical sampling plans to develop process stability characteristics. • Directly supervises Quality Supervisor and Quality Engineer. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, training employees, planning, assigning, appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Show less

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  Monarch Medical Technologies

  Dec 2021 - now

  • Provides strategic direction and leadership for the regulatory affairs department within an organization.• Ensures compliance with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, operating procedures, processes and task assignments• Develop and implement regulatory strategies that align with the organization's business objectives.• Member of executive management with responsibility and authority for the Quality Management System• Provides regulatory leadership to company departments and teams• Manages budget and resources within the regulatory affairs department to support its activities effectively.• Acts as a liaison with other departments, including Quality Assurance, R&D, Product, Legal, Professional Services, Marketing and Clinical Affairs• Leads regulatory strategy formulation, submission preparation and development • Develops global regulatory strategies for new and modified medical devices• Maintains Standards of Practices (SOPs) and provides training and updates on new FDA guidance, communications, and competitive cleared devices.• Prepares submissions for new devices and manufacturing or device changes• Provides definition, direction and support of regulatory activities, including complaint handling and standard documentation• Ensures that complaints are investigated and documented thoroughly in compliance with the applicable regulations• Conducts audits of and compliance of complaint management system• Reviews product and manufacturing changes for compliance with regulations (change control)• Reviews protocols and reports to support regulatory compliance for product changes and submissions• Reviews device labeling and advertising materials for FDA submissions and applicable regulations• Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body)• Support all company initiatives in QMS, EMS and other regulatory requirements Show less • Ensures compliance with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, operating procedures, processes and task assignments• Member of management with responsibility and authority for the Quality Management System• Provides regulatory leadership to company departments and teams• Acts as a liaison with other departments, including Quality Assurance, R&D, Product, Legal, Professional Services, Marketing and Clinical Affairs• Leads regulatory strategy formulation, submission preparation and development • Develops global regulatory strategies for new and modified medical devices• Maintains Standards of Practices (SOPs) and provides training and updates on new FDA guidance, communications, and competitive cleared devices.• Prepares submissions for new devices and manufacturing or device changes• Provides definition, direction and support of regulatory activities, including complaint handling and standard documentation, as required by FDA • Ensures that complaints are investigated and documented thoroughly in compliance with the FDA medical device regulations• Conducts audits of and compliance of complaint management system• Reviews product and manufacturing changes for compliance with regulations (change control)• Reviews protocols and reports to support regulatory compliance for product changes and submissions• Reviews device labeling and advertising materials for FDA submissions and applicable regulations• Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body)• Support all company initiatives in QMS, EMS and other regulatory requirements Show less

  • Senior Vice President Regulatory Affairs and Compliance

    Feb 2024 - now

  • Vice President of Regulatory Affairs and Compliance

    Dec 2021 - Feb 2024