15+ Years Medical Device/Pharmaceutical; Senior Management Oversight of/Experienced in:
• Lab/Manufacturing/R&D/PDP/Supply/Software systems
• Products: In-vitro Diagnostic Kits; Defibrillators; Imaging, Cardiovascular (includes combination products); Peripheral, Heart Therapy, Urology, Guidewires and Vascular
• Quality System development, implementation and effectiveness (Incoming through sterilization and batch release)
• Regulatory Affairs International and US, development of global regulatory affairs standard operating systems; develop global Regulatory and Clinical strategies with Agencies (PMDA, CANADA, TUV, BSI, KEMA, FDA); create all pre and post market submissions (examples: IDE, PMA, 510k, Technical Files, Design Dossiers, 806 reports all markets)
• Creating, reviewing and approving validation protocols and reports for:
*Software /Document and Design Changes/Methods/Sterilzation/Validations/Qualifications/Nonconformances/COA’s/Audits/ Out of Specifications/Trends/Stability/Engineering documents
• Method development and implementation (R&D to Production across multiple sites)
• Development of Testing Labs for cGMP/GLP compliance
• Application of Six Sigma to problem solving (DMAIC/DFSS process)
• Providing direction of working knowledge in 21 CFR Parts 21, 210, 211, 14, 806, 807, and 820; MDD; ISO/ICH/USP/ASTM
• Software Applications:
*LIMS/Access/PowerPoint/SharePoint/StatGraphics/ Project/Visio/Minitab/Word/Excel/Agile/PDM
• Lean Metrics and driving execution to those metrics
• QSIT/HACCP Auditing
General: I have been responsible for creating, managing, staffing, training, supporting, and improving the growth of Global Regulatory and Quality Affairs. I have provided regulatory and quality guidance to Medical Device Executives across a variety of product types by proactively identifying multi-site system improvement areas along with effectively communicating current Global Agency expectations to ensure business success. I have working knowledge of Global Standards and Requirements as well as current industry interpretation of these regulations to support many different types of clinical strategies and regulatory submissions along with having led many successful internal, FDA, and EMEA Audits to date. I have in depth hands on experience in many departmental areas of the medical device industry managing many different kinds of projects, from design through manufacturing and software, to incoming materials through packaging, microbiology, sterilization and final batch release. I take personal pride in exact execution and promote collaboration across all internal groups as well as drive consistent communication with all impacted Global Agencies. Additionally: Create SOPs for all aspects (Food, Medical including combination products, and Laboratory); Setting up cGMP, HACCP, Global Regulatory procedures, Quality Systems and Training. Create and successfully submit all Pre market and Post Market Regulatory Submissions (IDE, 501k, Tech Files, Design Dossiers, PMA etc.. )