Experience

Neocis

• United States
• Medical Equipment Manufacturing
• 100 - 200 Employee

• VP RA/QA

  • Apr 2021 - Present



Navellant Consulting

• Ft. Lauderdale, FL

• Principal Consultant

  • Feb 2020 - Present

  - Medical device global regulatory consultancy with particular focus on devices involving medical robotics, orthopedic implants, digital health, AI/machine learning, XR. Some devices include the following: + Military health research devices; Vascular injury trauma shunt; concussion management app; VR/AR ML-based concussion management app; peripherally inserted central catheter (PICC) with app; novel infusion port system for better management of diabetes; orthopedic, gynecologic robotic… Show more - Medical device global regulatory consultancy with particular focus on devices involving medical robotics, orthopedic implants, digital health, AI/machine learning, XR. Some devices include the following: + Military health research devices; Vascular injury trauma shunt; concussion management app; VR/AR ML-based concussion management app; peripherally inserted central catheter (PICC) with app; novel infusion port system for better management of diabetes; orthopedic, gynecologic robotic platforms; consumer sleep aid software app; peritoneal dialysis app; neonatal heart rate monitoring app; Autism diagnostic app Show less - Medical device global regulatory consultancy with particular focus on devices involving medical robotics, orthopedic implants, digital health, AI/machine learning, XR. Some devices include the following: + Military health research devices; Vascular injury trauma shunt; concussion management app; VR/AR ML-based concussion management app; peripherally inserted central catheter (PICC) with app; novel infusion port system for better management of diabetes; orthopedic, gynecologic robotic… Show more - Medical device global regulatory consultancy with particular focus on devices involving medical robotics, orthopedic implants, digital health, AI/machine learning, XR. Some devices include the following: + Military health research devices; Vascular injury trauma shunt; concussion management app; VR/AR ML-based concussion management app; peripherally inserted central catheter (PICC) with app; novel infusion port system for better management of diabetes; orthopedic, gynecologic robotic platforms; consumer sleep aid software app; peritoneal dialysis app; neonatal heart rate monitoring app; Autism diagnostic app Show less



getSALTY

• Miami/Fort Lauderdale Area

• el jefe

  • Jun 2011 - Present

  Project to create a social platform that can be used to monetize any digital content related to the creative ecosystem of surfing. Yew!! www.getsalty.com Project to create a social platform that can be used to monetize any digital content related to the creative ecosystem of surfing. Yew!! www.getsalty.com



Independent Regulatory Consulting

• Ft. Lauderdale, FL

• Independent Contractor

  • Jan 2014 - Jan 2020

  - Provide regulatory consulting (e.g., FDA, MDD) during to regulated industry + Dental surgery robot (K161399, K173402) - Provide regulatory consulting (e.g., FDA, MDD) during to regulated industry + Dental surgery robot (K161399, K173402)



Magic Leap

• United States
• Computers and Electronics Manufacturing
• 700 & Above Employee

• Director of Regulatory Affairs

  • Mar 2015 - Aug 2019

  - Built ML consumer product regulatory function (people, process) from ground-up to enable launch of ML1 into markets including but not limited to: * US (Part 15 of FCC rules) * Canada (Class B digital device compliance with CAN ICES-3(B)/NMB-3(B)) * EU (2014/53/EU RED, 2014/35/EU LVD, 2011/65/EU RoHS, EN 60950-1) - Defined and led implementation of regulatory strategy for all healthcare initiatives as related to: * FDA (consumer product vs SaMD/SiMD) … Show more - Built ML consumer product regulatory function (people, process) from ground-up to enable launch of ML1 into markets including but not limited to: * US (Part 15 of FCC rules) * Canada (Class B digital device compliance with CAN ICES-3(B)/NMB-3(B)) * EU (2014/53/EU RED, 2014/35/EU LVD, 2011/65/EU RoHS, EN 60950-1) - Defined and led implementation of regulatory strategy for all healthcare initiatives as related to: * FDA (consumer product vs SaMD/SiMD) * EU (MDD/MDR) * 60601-1 (baseline consumer product vs medical device) - Created strategy for proactive outreach to applicable regulatory agencies (e.g., FDA, CPSC) and standards committees (e.g., UL, IEEE) to establish positive working relationship and help shape policy - Proactive establishment of cybersecurity function (people/process) within healthcare team to be in alignment with FDA requirements - Some other key team accomplishments included: * FDA Establishment Registration for ML as a specification developer for Class I medical device (#3012334250) * 21 CFR 820 complaint QS implementation to support registration with FDA * Obtained FDA accession number for Class I laser in ML1 by ensuring compliance to 21 CFR 1040 and EN/IEC 60825-1 - Interim Healthcare Team Lead for about 1.5 yrs in addition to regulatory responsibility during search for FT lead - Regulatory lead at ML for working with Brainlab to support 510(k) clearance of spatial computing version of Brainlab Elements DICOM Viewer (K191014) Show less - Built ML consumer product regulatory function (people, process) from ground-up to enable launch of ML1 into markets including but not limited to: * US (Part 15 of FCC rules) * Canada (Class B digital device compliance with CAN ICES-3(B)/NMB-3(B)) * EU (2014/53/EU RED, 2014/35/EU LVD, 2011/65/EU RoHS, EN 60950-1) - Defined and led implementation of regulatory strategy for all healthcare initiatives as related to: * FDA (consumer product vs SaMD/SiMD) … Show more - Built ML consumer product regulatory function (people, process) from ground-up to enable launch of ML1 into markets including but not limited to: * US (Part 15 of FCC rules) * Canada (Class B digital device compliance with CAN ICES-3(B)/NMB-3(B)) * EU (2014/53/EU RED, 2014/35/EU LVD, 2011/65/EU RoHS, EN 60950-1) - Defined and led implementation of regulatory strategy for all healthcare initiatives as related to: * FDA (consumer product vs SaMD/SiMD) * EU (MDD/MDR) * 60601-1 (baseline consumer product vs medical device) - Created strategy for proactive outreach to applicable regulatory agencies (e.g., FDA, CPSC) and standards committees (e.g., UL, IEEE) to establish positive working relationship and help shape policy - Proactive establishment of cybersecurity function (people/process) within healthcare team to be in alignment with FDA requirements - Some other key team accomplishments included: * FDA Establishment Registration for ML as a specification developer for Class I medical device (#3012334250) * 21 CFR 820 complaint QS implementation to support registration with FDA * Obtained FDA accession number for Class I laser in ML1 by ensuring compliance to 21 CFR 1040 and EN/IEC 60825-1 - Interim Healthcare Team Lead for about 1.5 yrs in addition to regulatory responsibility during search for FT lead - Regulatory lead at ML for working with Brainlab to support 510(k) clearance of spatial computing version of Brainlab Elements DICOM Viewer (K191014) Show less



Stryker

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

• Director, Regulatory

  • Jan 2014 - Mar 2015

  - Transitioned from MAKO Surgical Corp. to StrykerMAKO after acquisition. Job description basically the same. - Ongoing regulatory support during Stryker integration US CLEARANCES - Obtained the following MAKO robotic arm 510ks: K141989 (RIO Stryker THA), K143752 (RIO Stryker Total Knee App) - Obtained the following MAKO implant 510ks: K142606 (Trident Tritanium PST Acetabular Shell), K143635 (Kinetis Total Knee), K150307 (Restoris MCK update), K150410 (Restoris Porous… Show more - Transitioned from MAKO Surgical Corp. to StrykerMAKO after acquisition. Job description basically the same. - Ongoing regulatory support during Stryker integration US CLEARANCES - Obtained the following MAKO robotic arm 510ks: K141989 (RIO Stryker THA), K143752 (RIO Stryker Total Knee App) - Obtained the following MAKO implant 510ks: K142606 (Trident Tritanium PST Acetabular Shell), K143635 (Kinetis Total Knee), K150307 (Restoris MCK update), K150410 (Restoris Porous update) - IDE approval of RIO Stryker TKA application EU - MHRA approval for clinical investigation of a new MAKO application. Show less - Transitioned from MAKO Surgical Corp. to StrykerMAKO after acquisition. Job description basically the same. - Ongoing regulatory support during Stryker integration US CLEARANCES - Obtained the following MAKO robotic arm 510ks: K141989 (RIO Stryker THA), K143752 (RIO Stryker Total Knee App) - Obtained the following MAKO implant 510ks: K142606 (Trident Tritanium PST Acetabular Shell), K143635 (Kinetis Total Knee), K150307 (Restoris MCK update), K150410 (Restoris Porous… Show more - Transitioned from MAKO Surgical Corp. to StrykerMAKO after acquisition. Job description basically the same. - Ongoing regulatory support during Stryker integration US CLEARANCES - Obtained the following MAKO robotic arm 510ks: K141989 (RIO Stryker THA), K143752 (RIO Stryker Total Knee App) - Obtained the following MAKO implant 510ks: K142606 (Trident Tritanium PST Acetabular Shell), K143635 (Kinetis Total Knee), K150307 (Restoris MCK update), K150410 (Restoris Porous update) - IDE approval of RIO Stryker TKA application EU - MHRA approval for clinical investigation of a new MAKO application. Show less



MAKO Surgical Corp.

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

• Co-founder, Director-Regulatory Affairs

  • Nov 2004 - Dec 2013

  - Responsible for obtaining RA clearances for all MAKO products (robotic arm platform, implants) for WW marketing efforts. - Implemented MAKO QS and obtained initial ISO 13485 certification from BSI. - Established RA-QA department at MAKO by building department from ground up by transitioning function from parent company (Z-KAT) to MAKO and by hiring for additional department positions where required. - Represented RA-QA function for investor due diligence during Series A, B, C… Show more - Responsible for obtaining RA clearances for all MAKO products (robotic arm platform, implants) for WW marketing efforts. - Implemented MAKO QS and obtained initial ISO 13485 certification from BSI. - Established RA-QA department at MAKO by building department from ground up by transitioning function from parent company (Z-KAT) to MAKO and by hiring for additional department positions where required. - Represented RA-QA function for investor due diligence during Series A, B, C financing including subsequent IPO of MAKO common stock (NASDAQ: MAKO) with JP Morgan, Cowen, Morgan Stanley, and Wachovia Securities. - Implemented MAKO's first clinical research program with electronic clinical data management and IRB approval at local FTL hospital. - Represent MAKO at Ortho Surgery Manufacturers Assoc. (OSMA) - Interfaced with 3rd party ortho implant manufacturers to integrate 3rd party implants/instruments into TGS/RIO - Provide proper communication to FDA and international regulatory bodies re adverse event and corrections/removal reports. - Represented RA function during due diligence in preparation for MAKO acquisition. US CLEARANCES - Obtained MAKO's 1st FDA clearance for 1st generation robotic arm platform in 30 days via Special 510k. - Robotic arm 510ks: K050973 (Voyager Linux-TGS), K052851 (Voyager/TGS-CT), K072806 (TGS), K081867 (TGS v2.0 aka RIO), K083644 (TGS-Hip), K091998 (RIO-Hip), K093425 (RIO-THA), K112507 (Restoris PKA v2.5), K121064 (Makoplasty Hip 2.0), K141989 (Makoplasty Hip), TKA App (K143752), PKA App (K142530) - MAKO implant 510ks: K060017 (MAKO Uni Knee System-Restoris Inlay), K073248 (MAKO Uni Knee-Restoris Onlay), K080368 (MAKO Uni Knee II), K080029 (MAKO PF Knee), K082081 (MAKO Uni Knee III), K082088 (MAKO PF Knee II), K082172 (MAKO Modular Knee aka Restoris MCK), K090763 (Restoris MCK-Lateral Uni), K133039 (MCK Esyntial (Vit E)) - Conducted pre-IDE meeting with FDA in MD to discuss regulatory strategy for upcoming MAKO products

• Co-founder, Director, Regulatory Affairs

  • Nov 2004 - Dec 2013

  EU - Obtained 1st international regulatory clearance for the EU for the TGS/RIO system: CE certificate #531830 - Expanded scope of MAKO QMS certification from devices for computer-assisted surgery to include orthopedic implants. - Obtained CE Mark clearance for MAKO implants: CE certificate #558657 (Restoris MCK), CE certificate #547180 (Restoris Uni Knee) - Expanded scope of RIO CE cert to include total hip arthroplasty CANADA - Obtained medical device license for RIO… Show more EU - Obtained 1st international regulatory clearance for the EU for the TGS/RIO system: CE certificate #531830 - Expanded scope of MAKO QMS certification from devices for computer-assisted surgery to include orthopedic implants. - Obtained CE Mark clearance for MAKO implants: CE certificate #558657 (Restoris MCK), CE certificate #547180 (Restoris Uni Knee) - Expanded scope of RIO CE cert to include total hip arthroplasty CANADA - Obtained medical device license for RIO system for partial knee replacement: Lic # 85080 - Obtained medical device license for RIO associated instruments for partial knee replacement : Lic #'s 83708, 83709, 83710, 83711, 83932, 86218, 86220, 87502, 87503, 87504, 87505, 87506, 87507, 87508 - Obtained medical device license for Restoris MCK implant system: Lic # 85804 - Obtained updated #85080 license for RIO system for total hip arthroplasty KOREA - Obtained KFDA clearance for MAKO's Restoris MCK implant system (Lic # Suheo 11-565) - Obtained KFDA clearance for MAKO's RIO System (Lic # Suheo 11-821) SINGAPORE: - Clearance for marketing for RIO and Restoris MCK implant HONG KONG: - Clearance for marketing for RIO and Restoris MCK implant JAPAN - Met with PMDA in Tokyo to discuss MAKO products and overall strategy used for current clearances in order to support regulatory submission in Japan. AUSTRALIA - Successful registration of MAKO products in Australia (ARTG #'s 196525, 196526, 196527, 196619, 196660) TURKEY - Successful registration of MAKO products in Turkey THAILAND - Successfully completed registration of MAKO's knee and hip products in Thailand CHINA - Met with CFDA in Beijng to discuss MAKO products and overall strategy used for current clearances in order to support regulatory submission in China.



Z-KAT, Inc.

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Co-founder; Director, Regulatory Affairs / Quality Assurance

  • Mar 1997 - Nov 2004

  - Responsible for regulatory affairs and quality assurance function at Z-KAT. Obtain regulatory clearance for all Z-KAT products to support domestic and international marketing efforts. - Implemented Z-KAT quality system and obtained ISO 9001 and ISO 13485 certification from BSI. - Established RA-QA department at Z-KAT by building department from ground up with hires for doc control, receiving inspection, software quality engineer, regulatory associate. - Obtained the following 510k… Show more - Responsible for regulatory affairs and quality assurance function at Z-KAT. Obtain regulatory clearance for all Z-KAT products to support domestic and international marketing efforts. - Implemented Z-KAT quality system and obtained ISO 9001 and ISO 13485 certification from BSI. - Established RA-QA department at Z-KAT by building department from ground up with hires for doc control, receiving inspection, software quality engineer, regulatory associate. - Obtained the following 510k clearances for Z-KAT products: K984298 (FGS Mk I), K002893 (Fluorolab Plus), K013025 (Modification to Fluorolab Plus), K023975 (Voyager Linux), Z-BOX (K030764) - Z-KAT lead for partnership with Biomet Orthopedics to obtain regulatory clearance for Z-KAT/Biomet Acumen Surgical Navigation products: K031337 (Acumen System for Uni Knee), K031732 (Acumen System for spine), K031454 (Acumen System for total knee) - Obtained Z-KAT's 1st international regulatory clearance for CE Mark: CE certificate # 69636 (Voyager Surgical Navigation System) Show less - Responsible for regulatory affairs and quality assurance function at Z-KAT. Obtain regulatory clearance for all Z-KAT products to support domestic and international marketing efforts. - Implemented Z-KAT quality system and obtained ISO 9001 and ISO 13485 certification from BSI. - Established RA-QA department at Z-KAT by building department from ground up with hires for doc control, receiving inspection, software quality engineer, regulatory associate. - Obtained the following 510k… Show more - Responsible for regulatory affairs and quality assurance function at Z-KAT. Obtain regulatory clearance for all Z-KAT products to support domestic and international marketing efforts. - Implemented Z-KAT quality system and obtained ISO 9001 and ISO 13485 certification from BSI. - Established RA-QA department at Z-KAT by building department from ground up with hires for doc control, receiving inspection, software quality engineer, regulatory associate. - Obtained the following 510k clearances for Z-KAT products: K984298 (FGS Mk I), K002893 (Fluorolab Plus), K013025 (Modification to Fluorolab Plus), K023975 (Voyager Linux), Z-BOX (K030764) - Z-KAT lead for partnership with Biomet Orthopedics to obtain regulatory clearance for Z-KAT/Biomet Acumen Surgical Navigation products: K031337 (Acumen System for Uni Knee), K031732 (Acumen System for spine), K031454 (Acumen System for total knee) - Obtained Z-KAT's 1st international regulatory clearance for CE Mark: CE certificate # 69636 (Voyager Surgical Navigation System) Show less



Mekanika

• Miami/Fort Lauderdale Area

• Test Engineer

  • 1996 - 1997

  Responsible for mechanical/performance testing on innovative composite spinal implants. Responsible for mechanical/performance testing on innovative composite spinal implants.



Waldemar Link GmbH & Co. KG

• Germany
• Medical Equipment Manufacturing
• 100 - 200 Employee

• S FL Distributor

  • 1996 - 1997

  S FL distributor of orthopedic implant and instrumentation manufacturer in Hamburg, Germany S FL distributor of orthopedic implant and instrumentation manufacturer in Hamburg, Germany



Lima Corporate

• Italy
• Medical Equipment Manufacturing
• 700 & Above Employee

• Product support/sales engineer

  • 1995 - 1996

  US product support/sales engineer of orthopedic implant manufacturer in Italy US product support/sales engineer of orthopedic implant manufacturer in Italy



Bascom Palmer Eye Institute

• United States
• Hospitals and Health Care
• 300 - 400 Employee

• Research Assistant-Polymer & Laser Lab, Ophthalmic Biophysics Ctr, BPEI, U Miami School of Med

  • 1992 - 1995

  Development of laser interferometry measurement device and 5-fluorouracil ocular implants for treatment of glaucoma. Development of laser interferometry measurement device and 5-fluorouracil ocular implants for treatment of glaucoma.