Kora Marinkovic Email & Phone Number

San Diego, California, US

San Diego, California, US

San Diego, California, US

• 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.
• 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

San Diego, California, US

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.

• 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

• 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

Specialized Certificate, Regulatory Affairs

Mba, Marketing

Marketing

Certificate In International Business

Graduate Program In Sociology

B.A., Sociology