AUSTIN, September 2021: OriGen Biomedical, Inc., a leading producer of cryopreservation, cell culture, and respiratory products, is pleased to announce that David Jones has joined OriGen Biomedical as Director of Quality and Regulatory Affairs, effective June 2021. Beth San Segundo, our President and CEO, has filled this role since January 2021.
David has over 25 years of experience in leadership roles for Regulatory, Quality, and Clinical Medical Devices. David has a thorough understanding of FDA requirements (as a former FDA officer), having performed over 400 FDA audits and personally written over fifty FDA submissions. David also has extensive experience in Quality Systems certifications and international submissions, including CE Mark, CSA, TGA, JPAL, etc. OriGen’s future and David’s aptitude, attitude, and experience are well-suited for OriGen’s goals for the position.
David’s impressive career has included executive roles at Berlin Heart, Remicalm, LipoScience, Millar Instruments, LeoCor, among others, where he demonstrated great success as an accomplished quality, operations, and regulatory expert. David received his B.Sc. in Healthcare Administration from Texas State University.
“We are very pleased to welcome David Jones to OriGen as we continue to grow and evolve with our customer’s needs. David has extensive experience in dealing with US, EU, and International regulatory agencies that we believe will be invaluable. He has worked with a wide range of products in devices, drugs, biologics, and IVDs. We look forward to working with him on both existing and new products,” said Richard Martin, Founder of and Chairman of the Board at OriGen Biomedical.
David Jones adds, “I am excited to join OriGen, I don’t think in my 25-plus years in quality and regulatory I’ve ever worked with such a positive, happy group of people. I see regulatory and quality as a partnership with all departments and welcome cross-functional participation. I look forward to leading our Quality/Regulatory team to help OriGen reach our goals, as we have lots of interesting and challenging work in front of us.”
OriGen welcomes David to this new role and is excited to support his efforts to help create innovative medical products that improve people’s lives.
CONTACT:
Kirstenk Krupps – Marketing Manager
OriGen Biomedical, Inc.
k.krupps@origenbio.com
512-474-7278
David has over 25 years of experience in leadership roles for Regulatory, Quality, and Clinical Medical Devices. David has a thorough understanding of FDA requirements (as a former FDA officer), having performed over 400 FDA audits and personally written over fifty FDA submissions. David also has extensive experience in Quality Systems certifications and international submissions, including CE Mark, CSA, TGA, JPAL, etc. OriGen’s future and David’s aptitude, attitude, and experience are well-suited for OriGen’s goals for the position.
David’s impressive career has included executive roles at Berlin Heart, Remicalm, LipoScience, Millar Instruments, LeoCor, among others, where he demonstrated great success as an accomplished quality, operations, and regulatory expert. David received his B.Sc. in Healthcare Administration from Texas State University.
“We are very pleased to welcome David Jones to OriGen as we continue to grow and evolve with our customer’s needs. David has extensive experience in dealing with US, EU, and International regulatory agencies that we believe will be invaluable. He has worked with a wide range of products in devices, drugs, biologics, and IVDs. We look forward to working with him on both existing and new products,” said Richard Martin, Founder of and Chairman of the Board at OriGen Biomedical.
David Jones adds, “I am excited to join OriGen, I don’t think in my 25-plus years in quality and regulatory I’ve ever worked with such a positive, happy group of people. I see regulatory and quality as a partnership with all departments and welcome cross-functional participation. I look forward to leading our Quality/Regulatory team to help OriGen reach our goals, as we have lots of interesting and challenging work in front of us.”
OriGen welcomes David to this new role and is excited to support his efforts to help create innovative medical products that improve people’s lives.
About OriGen Biomedical
OriGen Biomedical, Inc. is a leading producer of cryopreservation, cell culture, and intensive respiratory care products. OriGen’s focus is to produce a range of products to support the treatment of cancer, genetic conditions, and other life-threatening diseases. Our products are designed with the patient and user in mind and we strive to maintain excellent customer service to ensure that patient care is the priority. Quality is the foundation of all product designs at OriGen, and each product is produced with the intention that it will improve patient health. Founded in 1997 and headquartered in Austin, Texas, OriGen is certified annually to ISO 13485 standards and regularly inspected by the FDA, MDSAP, ISO certification organizations, and our customers. Follow us on LinkedIn here.CONTACT:
Kirstenk Krupps – Marketing Manager
OriGen Biomedical, Inc.
k.krupps@origenbio.com
512-474-7278