OMID SOURESRAFIL

Del Mar • 612-***-**** • adzhvo@r.postjobfree.com

Medical Device Clinical/Regulatory Expert

Senior Medical Device Consultant •in Regulatory Affairs, FDA, EU MDR, 510(k) PMA, Chief Technology Officer • CEO Senior Clinical Research Manager Medical Device Innovation • Regulatory Compliance Strategy • Clinical Research Design

Rapid Product Development • Expert Regulatory Approvals • Innovative Medical Devices

WORK EXPERIENCE

Independent Regulatory April 2019 - present

Clinical And Product Development Consultant

Consult with several clients on the development of regulatory documentation from strategy, to submissions including 510(k), Supplements, PMA and IDE for regulatory approval of medical devices

Composed and filed Intellectual Property for innovative Neuromodulation, cardiovascular, and AI-based medical devices targeting various disease states.

Orchestrated clinical, regulatory, and product strategies for medical companies.

Smiths Medical March 2018 - March 2019

Senior Principal Regulatory Affairs Advisor (Contract)

Managed regulatory documentation for Drug Pumps (combination devices) reviewing, organizing, updating documents, ensuring accuracy and accessibility for devices, for all stakeholders including internal and external (FDA, notified bodies).

Compiled concise Clinical Evaluation Reports, analyzing data, patient outcomes, safety, efficacy, and potential adverse effects.

Championed developing, upgrading, and maintaining device files for regulatory bodies.

Compiled 510(k), 510(k) supplements internal quality documents such as SOPs, and other documents.

SmartImplantSystems Nov 2016 - March 2018

CEO

Contributed to ISO13485 quality system establishment and risk assessment initiatives.

Cultivated cadaver research at labs, collaborating with renowned experts, through dissection and examination for knowledge gain.

Supervised a diverse team in developing an innovative spine fusion device, overseeing collaboration and ensuring quality.

Unified experts across disciplines for a well-structured, interdisciplinary collaboration.

Engineered neuromodulation/spine fusion device prototypes and intellectual property.

Streamlined project plans by managing development and quality assurance timelines.

Collaborated on strategies for initial clinical testing of implantable devices.

Negotiated FDA pre-submission documents and clinical study plans.

Nov 2012 - June 2013

Clinical Development Specialist QiG (Contract)

Fostered growth in clinical programs through multidisciplinary team engagement.

Accelerated development of pre-clinical initiatives drove crucial advancements.

Feb 2012 - Aug 2016

CEO Embomedics

Founded, funded and staffed a startup company active in the area embolization and oncology.

Optimized EmboMedics' operations by creating an efficient quality management system covering all organizational aspects.

Enabled device/drug combo success via strategic clinical and regulatory programs.

Supervised documentation creation and quality systems for high-quality products.

Structured regulatory pathways, negotiated with FDA for product compliance.

Negotiated a strategic partnership for sales and eventual acquisition of the company.

Medtronic Feb 2012 - Feb 2013

Clinical Project Manager (Contract)

Navigated site selection for clinical trials by evaluating locations, considering accessibility, infrastructure, skilled personnel, and proximity.

Shaped efficient device distribution and allocation through strategic planning, streamlining processes, and ensuring seamless resource flow.

Managed development, implementation, and execution of data management plans, coordinating IT, marketing, and finance teams to ensure a.

Directed training for field personnel and physicians on cutting-edge technologies.

Mobilized clinical trials from strategy to implementation pre and post market.

Refocused on impactful post-market activities, our team diligently developed.

Aligned with physicians in designing and developing novel research projects.

Customized liaison with FDA during Pre-IDEs and device protocol approvals.

Drove planning, execution for influential publications' development.

Sorin Group Feb 2009 - Feb 2012

Senior Advisor Of Clinical Affairs/Clinical Project Manager

Handpicked prime locations, our team considered accessibility, demographics, and healthcare proximity, diligently analyzing each site.

Engaged physicians collaboratively designed innovative research projects to advance medical knowledge and improve patient care.

Formulated precise budgets for clinical projects, considering costs, overheads, compliance, and contingencies.

Managed device distribution and allocation effectively, assessing department needs, and meticulously planning.

Trained personnel in advanced technology, including software and medical equipment.

Spearheaded clinical trial design from strategy to development and implementation.

Devised a comprehensive data management strategy, including the establishment of.

Facilitated post-clinical activity planning and product market launch support.

Collaborated with the FDA during Pre-IDEs and device protocol discussions.

Authored numerous impactful publications, showcasing groundbreaking work.

Assessed clinical data, creating reports for investigator conferences.

St. Jude Medical Atrial Fibrillation division (company acquired) Feb 2008 - Feb 2009

Field Clinical Engineer

Collaborated in Electrophysiology Studies using NavX Electroanatomical Mapping Syste.

Partnered with R&D Team to innovate and validate catheter, RF generator designs.

Spearheaded management of clinical sites for the Atrial Fibrillation division.

Sep 2003 - Feb 2008

Impulse Dynamics

Field Clinical Engineer

Assisted physicians in technology implementation through support, solution analysis, seamless integration, and professional training for efficiency.

Streamlined clinical data collection and processing was expertly achieved using innovative technologies and advanced software solutions.

Managed device distribution, allocation, tracking, and assignment to appropriate personnel, considering their needs.

Facilitated physician protocol generation through active collaboration with diverse healthcare professionals.

Served as liaison between Research and Development (R&D) teams, ensuring communicati.

Championed publication development with company and physicians to prepare scripts.

Lectured at regional and national training programs for Training/Field Education.

Collaborated with FDA in Pre-IDE meetings and device protocol approvals.

Spearheaded selecting and assessing optimal clinical sites for.

Streamlined.

Prior Experience: Contractor to Medtronic, Senior Clinical Research Manager, Tuta Healthcare, Clinical and Regulatory Affairs Manager, ResMed Inc, Research Fellow, Applied Research Telectronics Pacing Systems, Research Engineer-(Biomedical Engineering) Department

EDUCATION

UNSW

Bachelors, Electrical Engineering

UNSW

BSc, Computer Science

UNSW

Doctorate, Biomedical Engineering

TECHNOLOGIES, CERTIFICATIONS

Technologies: C++, Oracle Database, MATLAB, SolidWorks, Python, Microsoft Project, AutoCAD, CTMS, Oracle Clinical,

Certifications: Six Sigma Green Belt, QSM, QSR, GCP, GMP, GLP, ISO13485 Development of implantable and External Sensors, Artificial Intelligence and Predictive Analytics tools

* Design, development and conduct of device based Clinical and Pre-Clinical Research projects.

* Experience in educating of physicians and support staff.

* Design and Implementation of various Pre-clinical trials for pilot studies of various implantable technologies.

* Management of scientific/animal studies and clinical projects.

* Hands-on experience obtaining Regulatory Approvals for medical devices, CE, PMA, IDE and 510(k).

* Quality assurance ISO and EN and FDA and specialty documentation needs for GMP GLP and GCP compliance.

Quality Training:

1. Good laboratory Practice (GLP)

2. Good Manufacturing Practice (GMP)

3. Good Clinical Research Practice (GCP).

4. Internal Auditor Training

5. Lead Auditor Training

6. Introduction to ISO 9000:2000

7. Six Sigma Champion Level

8. Six Sigma Green Belt

9. Design and Implementation of an ISO 13485 Quality System

10. Risk Analysis for Medical Devices - (AAMI) October 2003

11. Introduction to ISO 14155

12. Clinical Trials Design & Analysis Workshop

13. Monitoring of Clinical Trials.

14. CTMS

15. Oracle Clinical • Electrocardiogram

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