Irina Kulinets

About Irina Kulinets

I bring to the Linked-In community my knowledge, expertise and strategic/operational experience in medical devices, biotechnology and pharmaceutical regulatory affairs, clinical trials, HEOR and quality assurance. My special interest is to share with the peer community my knowledge, understanding, and if appropriate, contacts in the USA and global medical device, pharmaceutical and biotechnology sectors. Our common areas of interest may include: regulatory and clinical research intelligence; regulatory and clinical research strategies to achieve the broader market access; strategizing device, pharmaceutical and biologic regulatory submissions; as well as the effective and economical design of clinical trials to support medical products claims, and clinical trials conducted in the US and abroad. I would also like to network with those who are interested in leveraging collaboration/communications methodologies with FDA, EMEA and international regulatory authorities, as well as within the medical community; how to achieve product approvals within targeted timeframes; and discussing the nuances of defining, developing/implementing global regulatory, clinical and quality initiatives. Interesting topics of conversation include supporting corporate vision, mission and business objectives; handling domestic and international device, pharmaceutical and biologic regulatory filings and product registrations; developing and implementing state-of-the-art quality systems; as well as designing and executing all phases of pre-approval clinical trials and field evaluation clinical studies in the US and worldwide.Notable entities include: FDA, Notified Bodies, EMEA, & Competent Authorities, Ministries of Health of Latin & South America, Health Canada, TGA, MHLW /CFDA (Japan), KFDA (Korea), CFDA (China) and other regulatory authorities worldwide.

Experience

1. Scientific Advisory Board

   Melior Capital Management

   Jan 2021 — Present

Education

• California State University

  MS, Quality Assurance

• Trident University International

  PhD, Health Science

• Belarus Polytechnic State University

  BS and MS, Mechanical Engineering

Skills

• Technical File
• Biotech Regulatory Affairs
• Biotechnology
• Drug-Device & Biologic-Device Combination Submissions
• Hazard Analysis
• 21 Cfr Part 11
• Clinical Affairs
• Medical Device Regulatory Affairs
• Pharmaceutical Regulatory Strategies
• Pma
• Sted Clinical Affairs
• Fda Regulatory Liaison
• Gmp
• Regulatory Authority Negotiations
• Clinical Strategies
• Iso 13485
• Strategic Partnerships
• Regulatory Affairs
• Medical Devices
• Clinical Research
• Capa
• Clinical Due Diligence
• Clinical Development
• Regulatory Submissions
• Sterilization Technologies
• Clinical Submissions
• Biopharmaceuticals
• International Regulatory Liaison
• 510k
• Design Dossier
• Medical Devices Regulatory Strategies
• Biotech Strategic Analysis
• Oncology
• Maa
• Reimbursement Strategies
• Risk Management
• Bla
• Ide
• Nda
• Clinical Trials