Regulatory Affairs Specialist @ - U.S. Class III PMA SME o Evaluate product design and manufacturing changes for class III impact and regulatory strategy o Prepare PMA supplements, 30-day notices, and annual report documentation - Knee Regulatory SME for legacy product DHF review o Coordinated regulatory affairs efforts in completing a total review of current product portfolio for compliance to new regulations since product launch - Developed processes for the review DHF and regulatory information - On-boarded, trained, and- assisted contract employees in DHF review processes and procedures - Provided guidance on any regulatory related questions including active guidance documents, standards, and testing that was originally submitted in device applications. - Developed timelines for implementation of regulatory deliverables o Participated on cross functional teams to review DHF information - Lead Regulatory Specialist on New Product Development teams o Develop regulatory strategy for marketing in US, EU, and rest of the world o Generate and manage submission documentation for regulatory agencies such as FDA and Notified Bodies o Submit U.S. 510(k)s, U.S PMA supplements, Design Dossiers, and EU change notices o Participate in Design and Risk Management document review - Review marketing collaterals for substantiation of claims. From August 2013 to Present (2 years 3 months) warsaw, indianaQuality Engineer @ CAPA Remediation Team Lead (Aug 2012-January 2013): -Led and participated in CAPA investigations across multiple subprocesses including: Quality Systems, Design, Management Controls, Validation, and Manufacturing. ---Tasks required included: -Ensuring compliance with internal and external procedures and regulations -Developing and managing project plan & time lines. -Documenting results of CAPA Activities ensuring a complete record -Completed CAPA related training including: -Root Cause Analysis & CAPA Implementation DMAIC Methodology - CAPA Effectiveness Verification -CAPA Process and System Tools Quality Engineer NPD Knees (January 2013-August 2013) -Managed the manufacturing quality control responsibilities on a joint product development project with the Winterthur site. Included working closely with our internal manufacturing group, suppliers, sourcing, and supplier quality. -Provided Quality Engineering support for new product introductions including: -Review and approval Design History File, Device Master Record, Risk Management File and capability study documents. -Reviewe and approval equipment installation, operational qualification, design, method, and process validations. -Participation in inspection gauge selection, documentation, and Gage R&R’s. -Assessing documents for compatibility to our internal procedures and external laws and regulations. Completed the following Training: -Introduction to Geometric Dimensioning & Tolerancing -Measurement System Analysis (MSA) Workshop From August 2012 to August 2013 (1 year 1 month) Warsaw, INBiomedical Engineer @ Office of Compliance, Division of Enforcement B, Vascular & Circulatory Support Branch -Performed reviews of Quality System information submitted in premarket approval (PMA) applications such as Original PMAs, 30-day notices, manufacturing site changes, and annual reports -Conducted Health Risk Assessments/Health Hazard Evaluations and classified medical device recalls -Reviewed and evaluated consumer/industry complaints and Establishment Inspection Reports, resulting in various actions including Warning Letters -Intermediate knowledge of 21 CFR 820 and 21 CFR 806 -Beginning knowledge of 21 CFR 1271 -Developing new process for Annual Report Review in a joint effort between OC/ODE -Working Group to increase communication between Office of Compliance and Office of Device Evaluation -Co-lead in the Development & Implementation of the new Division Hiring Team -CDRH Office of Compliance Award From September 2010 to August 2012 (2 years) Silver Spring, MDBiomedical Engineer @ Office of Device Evaluation, Circulatory Support & Prosthetics Devices Branch -Selected for 120-day detail as a reviewer in the Division of Cardiovascular Devices -Served as a reviewer of a variety of medical device actions, such as 510(k) submissions, investigational device exemptions (IDEs), pre-IDE submissions, and Premarket Approval (PMA) supplements. -Evaluates methods including bench testing, animal testing used in obtaining results to determine validity and scientific significance and to ensure that all information has been provided. -Works with a team of experts to obtain necessary consultation reviews for evaluating methods. -Enhanced professional career development by collaborating with other scientists in order to obtain a greater understanding of problems associated with medical devices. From February 2012 to May 2012 (4 months) Silver Spring, MDTeaching Assistant @ -Guided first-year students in the development of a simple cardiac model using MATLAB -Instructed a junior level bio-electronics laboratory -Guided students in the building of ECGs, pulse oximeters, etc. -Provided direction on the use of oscilloscopes and circuitry components -Increased student’s learning and comprehension by effectively communicating difficult subject matter From August 2008 to August 2010 (2 years 1 month) Engineering Intern @ -Lead compiler of instrumentation specification sheets of a team of 9 From June 2007 to September 2007 (4 months) Research Assistant @ -Developed finite element analysis models of the hip joint and elbow joint for mechanical evaluation From May 2006 to December 2006 (8 months) Toledo, Ohio AreaLaboratory Assistant @ -Completed DNA extraction and purification projects from various cell types (including whole blood, buccal, histological samples, etc) and analyzed results From May 2005 to December 2005 (8 months) Maryland

MS @ University of Toledo From 2008 to 2010 BS @ University of Toledo From 2003 to 2008 Andrea Artman, M.S. is skilled in: Medical Devices, Quality System..., Biotechnology, Biomechanics, Material..., Nanocomposites, SEM, Microsoft Office, Biomedical Engineering, Matlab, FDA, Characterization, CAPA, 21 CFR, Bioengineering, Materials Science, Quality System, Design of Experiments, Regulatory Affairs, Biomaterials, ISO 13485, Design Control, Product Development, Quality Control, GMP, Root Cause Analysis, Orthopedics, Laboratory, Quality Assurance