• Obtained clearances for Class II Medical Device (US, EU, Australia, N. Zealand, Canada, S Korea, Brazil, Israel) • Responsible for developing, implementing and managing the preparation of US and International regulatory submissions.• Responsible for product registration activities globally, including labeling, language translations and updates• Work closely with R&D and Operations departments, providing regulatory input and advice and ensuring regulatory compliance throughout the product lifecycle. • Define regulatory submission strategies throughout product development; manage submission timelines, interpret applicable regulations and guidelines for product team use; keep project team informed of regulatory decisions, issues, potential problems, and new regulations • Responsible for development, implementation and maintenance of QMS that is in compliance with ISO and FDA regulatory requirements. Also responsible for in-house regulatory requirements training • Responsible for review and impact assessment of key guidance documents, regulations and directives• Responsible for FDA and CADPH inspections and annual ISO 13485/MDD and Internal Audits• Responsible for resolution of regulatory compliance issues, CAPA and complaint investigation support, and support of post-market activities

As Director of Sales and Marketing responsible for developing and implementing a go-to-market plan for CorTechs' novel medical device technologies and for leading and managing all aspects of the company's sales and marketing activities.Effectively helped grow and transition CorTechs from a grant-based research firm into a viable medical products company that it is today. Spearheaded key wins that led to ongoing relationships with major medical centers and top research institutions.Cultivated lasting relationships of high mutual value within key accounts to ensure an understanding of their needs, communicate a sense of commitment, create a strong sense of brand loyalty within the customer base, and assist with creating and maintaining showcase customer sitesQuality and Regulatory responsibilities included managing FDA and CADPH inspections, annual Internal Audits and creating, implementing and maintaining Quality Management System.Responsible for FDA filings and correspondence with FDA.

Financial and Grants Management responsibilities included:• Performance monitoring, financial statements, budgets, financial analyses and reports preparation and reporting to the President• Conceived and executed cost controls• Responsible for the SBIR (NIH) grant administration, annual Indirect Rate Negotiations, A-133 Federal Grants Audits and Tax filingsAdministration/Operations Management responsibilities included: • Purchasing, contracting and inventory management• Office administration, payroll and human resources management• Creation and implementation of general office and business procedures, management of resourcesRegulatory and Quality responsibilities included FDA filings and correspondence, Quality Management System implementation, documentation and Patent filings

• Regular financial reporting including financial statements, budgets, financial analyses and reports preparation• Assisted with financial aspects of international projects with major global pharmaceutical, technology and OEM companies• Responsible for accounting, payroll, tax filings and control of departmental expenditures, managed all aspects of employee benefits programs• Successfully performed annual A-133 Federal Grants Audits • Managed NIH SBIR Grants programs including Indirect Rate Negotiations, preparation and submission of financial reports to NIH and compliance assurance• Created and implemented personnel policies and procedures ensuring compliance with employment laws and regulations• Responsible for contracts, consulting agreements and NDAs preparation • Responsible for purchasing, contracting, and maintenance of office equipment and InventoryRegulatory responsibilities included assisting with preparation of regulatory filings: 510(k), Patent and Trademark filings