Experience

Redica Systems

• United States
• Information Services
• 1 - 100 Employee

• Senior Vice President, MedTech

  • Apr 2022 - Present

  Redica Systems is a data and software company that provides regulatory and quality intelligence to FDA-regulated industries. The company serves 200+ pharmaceutical and medical device firms, helping them stay ahead of global regulatory changes, access extensive enforcement and inspection intelligence, monitor supplier risk, and improve team collaboration. Redica Systems is a data and software company that provides regulatory and quality intelligence to FDA-regulated industries. The company serves 200+ pharmaceutical and medical device firms, helping them stay ahead of global regulatory changes, access extensive enforcement and inspection intelligence, monitor supplier risk, and improve team collaboration.



ClearMark

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Founder

  • Jan 2019 - Present

  ClearMark is an electronic QMS specifically developed for Medical Device entrepreneurs, designers, and manufacturers. With a QMS that supports your business and organizes your team, products are developed on schedule and within budget. At ClearMark we believe your QMS should do more than just ensure compliance to ISO 13485 and 21 CRF 820; it should support your project goals from concept to post-marke ClearMark is an electronic QMS specifically developed for Medical Device entrepreneurs, designers, and manufacturers. With a QMS that supports your business and organizes your team, products are developed on schedule and within budget. At ClearMark we believe your QMS should do more than just ensure compliance to ISO 13485 and 21 CRF 820; it should support your project goals from concept to post-marke



Kaleidoscope Innovation Regulatory Affairs

• United States
• Medical Equipment Manufacturing

• Founder

  • Jan 2017 - Apr 2023

  Regulatory Mark is a Regulatory, Quality, and Clinical Affairs consulting firm specializing in the needs of medical device startups and entrepreneurs. We provide regulatory, quality and clinical solutions customized to your business. Regulatory Mark is a Regulatory, Quality, and Clinical Affairs consulting firm specializing in the needs of medical device startups and entrepreneurs. We provide regulatory, quality and clinical solutions customized to your business.



Medical Device Consulting

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Consultant

  • Oct 2014 - Apr 2023

  Providing consulting services for Regulatory, Clinical Affairs, and Quality Assurance applications for medical technology. I specialize in pre-IDE, IDE, PMA and 510(k) strategy and submissions, IRB submissions, clinical protocol development, and regulatory compliance. Areas of expertise include: laser and radiofrequency energy devices, software, medical mobile apps, implants, sterile products, cardiac, bariatric, general surgery and aesthetic medical products. Experienced with design controls, QSR, cGMPs, V&V, and risk management. Show less



Cynosure, LLC.

• United States
• Medical Equipment Manufacturing
• 500 - 600 Employee

• Director of Regulatory and Clinical Affairs

  • Sep 2014 - Sep 2015

  Responsible for “Ellman” division of Regulatory and Clinical affairs after acquisition of Ellman International by Cynosure Inc. Managed transition of all international regulatory licenses and contracts to reflect new manufacturer name/ownership including China, Russia, Singapore, KSA, UAE, Mexico and Canada. Managed transition and logistics of labeling in compliance with 70 countries registrations. Responsible for “Ellman” division of Regulatory and Clinical affairs after acquisition of Ellman International by Cynosure Inc. Managed transition of all international regulatory licenses and contracts to reflect new manufacturer name/ownership including China, Russia, Singapore, KSA, UAE, Mexico and Canada. Managed transition and logistics of labeling in compliance with 70 countries registrations.



Ellman, A Cynosure Company

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Director of Regulatory and Clinical Affiars

  • 2010 - Sep 2014

  Responsible for Regulatory and Clinical Affairs for company. Obtained registrations for all new products domestically and internationally including: China, Russia, Canada, Mexico, EU, Australia, UAE, KSA, and throughout Asia and Latin America. Responsible for Regulatory and Quality Assurance compliance for domestic and ISO 13485 requirements. Implemented clinical studies in support of premarket clearances and post market surveillance. Responsible for Regulatory and Clinical Affairs for company. Obtained registrations for all new products domestically and internationally including: China, Russia, Canada, Mexico, EU, Australia, UAE, KSA, and throughout Asia and Latin America. Responsible for Regulatory and Quality Assurance compliance for domestic and ISO 13485 requirements. Implemented clinical studies in support of premarket clearances and post market surveillance.



AtriCure, Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Regulatory and Clinical Affairs

  • 2004 - 2010