John Pappan

About John Pappan

https://calendly.com/jpge/15minJohn Pappan is a seasoned regulatory affairs professional focusing primarily in project management and regulatory compliance within the Medical Device and Bio-Tech Industries. John has experience in Medical Device Regulatory Affairs, Connected Healthcare, Artificial Intelligence and a vested interest in business development. In recent years, John has been working with global start-up companies with breakthrough technologies to bring revolutionary healthcare solutions into the global market. John\'s core expertise is bringing products from new product development to global market transfer and commercial release. He has worked with regulatory authorities and health care professionals from the U.S. FDA, E.U. Notified Bodies (KEMA, TUV, BSI), Competent Authorities, Health Canada, Australia’s Therapeutic Goods Administration (TGA), China’s State Food and Drug Administration (CFDA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and other international authorities of Latin America, Asia-Pacific and the Middle East; bringing to market safe and effective health care products and services. John excels at formulating strategies for regulatory submissions and in creating multidisciplinary teams to resolve regulatory hindrances. He works to ensure the strategic planning and preparation of FDA Pre-Submissions, Breakthrough Device Designation, IDEs, 510(k)’s, De Novo’s, PMA’s, CE Marking and international registrations. He also resolves regulatory concerns that arise via deficiency letters, product complaints, adverse events, recalls and oversee remediation activities to maintain regulatory compliance. John has extensive professional experience working with Nurses, Physicians, Surgeons, Regulatory Investigators, Auditors and Corporate Executives in various therapeutic areas including Dental Implants, Ophthalmology, Radiology, Cardiology, Endoscopic Technologies, Neurosurgery, Gynecology, Endo-surgery, Renal Therapies, and Diagnostic Devices. John\'s leadership in human resource management required for building and sustaining multidisciplinary teams for organizations is notable. He works to identify great talents in regulatory, clinical/medical, and quality assurance departments. Contact:Email: j•••@jpglobalenterprise.comX:@JohnJPGEPhone: 34••••••32https://calendly.com/jpge/15min

Experience

1. Regulatory Affairs Consultant

   The FDA Group

   Nov 2023 — Present

   The FDA Group helps life science organizations rapidly access the industry\'s best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.

Education

• Long Island University

  M.S, Pharmaceutical & Health Care Administration

  2009

• Fordham University Graduate School of Religion and Religious Education

  M.A, Religion and Religious Education

  2006

• Long Island University

  M.S, Regulatory Affairs

  2007

• Long Island University

  B.S, Biology, Minor in Business

Skills

• Fda
• Gmp
• Quality System
• Quality Systems
• V&V
• Clinical Development
• Medical Devices
• Capa
• Regulatory Strategy
• U.s. Food and Drug Administration (Fda)
• Gcp
• Biopharmaceuticals
• Pharmaceutics
• Glp
• 21 Cfr Part 11
• Design Control
• Software Development
• 510 K
• Quality Auditing
• Global Regulatory Compliance
• 21 Cfr
• Validation
• Regulatory Submissions
• Leadership
• Clinical Trials
• Product Development
• R&D
• Regulatory Requirements
• Ind
• Iso 13485
• Cross-Functional Team Leadership
• Strategy
• Iso 14971
• Life Sciences
• Biotechnology
• Regulatory Affairs
• Lifesciences
• Ce Marking
• Management
• Change Control