Creating, processing, and reviewing product documentation for submission to regulatory bodies (FDA, EMA) for registration of medical devices under different submission paths (De Novo, EUA / Emergency Use Authorization, U-EAU / Umbrella Emergency Use Authorization. 510(k) / Pre-Market Notification, PMA / Pre-Market Approval).
Research, verify, and approve device information in regulatory databases, such as e.g. active device registration & listings, GUDID, product classification, device class, product code, device definition, GMDN code, GMDN terms, GMDN term preferred name, GMDN title & number, device ID, device characteristics, etc.
Provide guidance to clients for registration of FURLS accounts.
Engage in submission of regulatory documents for PPE (Personal Protective Equipment), including surgical masks and respirators, N95 masks (US), KN95 masks (CN), FFP2/FFP3 masks, EU type IIR masks.
Engage in submission of regulatory documents for the De Novo registration of a Cold Ablation Robot-guided Laser Osteotome device.
Cyber Security assessment (device classification, assessment of potential threats, vulnerabilities, mitigation measures etc.) for the Cold Ablation Robot-guided Laser Osteotome as a Tier 2 device.
Serve as PRRC (Person Responsible for Regulatory Compliance) as defined by EU MDR 2017/745.
Advise a client (a major Swiss life science company) in regard to
? regulatory requirements (GxP, Cyber Security, etc.) when moving existing software applications used in a regulated environment, that are critical to product quality, into the cloud;
? regulatory requirements (GxP, Cyber Security, etc.) when deploying COTS applications in the cloud;
? regulatory requirements (GxP, Cyber Security, etc.) when developing new
applications in-house to be deployed in the cloud;
Consulting in regard to best practices for introducing and deploying a scaling agile methodology (in this case: SAFe) in DevSecOps and throughout the whole organization.
Consulting in regard to creating and implementing a Cloud Governance Framework that would blend in with, and complement, existent regulatory and quality corporate policies.
Helping clients to ideate, define, challenge and implement strategies, business models, target operating models, technologies and implementation roadmaps in order to master the challenges of Digital Transformation, the Internet of Things, Industry 4.0 topics, and relevant underlying or related technologies, such as Robotics, Factory Automation, Machine Learning, Cloud, etc.
Facilitating and leveraging methodologies and strategies such as Design Thinking, Innova- tion & Knowledge Management, Human-Centered Design, Customer Journey etc, to create awareness and build up momentum for implementing a truly Digital Culture throughout the entire organization, as an indispensable precondition of successful Digital Transformation.
Technological, social, economic aspects and effects of the Digital Transformation in general, and on a client?s specific business.
Big Data - how to generate, accumulate, manage, and mine them.
Cloudification of legacy on-premise systems and applications.
Possible application scenarios and advantages of blockchain technology.
The capabilities of Intelligent Robotics, Autonomous Systems, Machine Learning / AI, and how to put them to use in Factory Automation of Industry 4.0 manufacturing plants.
Head of the global program "Connectivity Solutions", the company's joint R&D effort in the Digital Transformation / IoT / Industry 4.0 domain.
Managing stakeholder and representing the program within the Belimed group and to external partners and clients.
Regulatory oversight (GRC) of the program.
Portfolio & product management, ideation, innovation and continuous improvement with
regard to the product ideas, prototypes and MVPs managed within the program.
Act as technical SPOC for R&D, internal stakeholders and external partners.
Development and definition of the R&D roadmap, product increments, MVPs, release milestones, coordination of the test management with external implementation partners.
Requirements elicitation / analysis / engineering with regard to functional and non- functional product, market, and regulatory requirements.
Subject matter expert for development of Belimed’s digital roadmap with focus on Digital Transformation, Internet of Things, Industry 4.0, Machine to Machine Communication, Big Data, Cloud Technology, and Advanced Analytics / Artificial Intelligence.
Project manager and subject matter expert for Belimed’s laboratory & equipment management system (ICS) and the development of its designated successor.
CynetiX Technology Consulting GmbH is a partner-managed Swiss consulting, research and development, and technology management firm, specializing in regulated and strictly quality driven industries, such as Medical Devices, Life Sciences, Aerospace, Defense, and Energy.
Providing consulting in the areas of Quality Assurance, Regulatory Affairs, and Governance/ Risk/Compliance to domestic and international clients in regulated industries, primarily in Medical Devices, Life Sciences, and Healthcare.
Special Operations (R&D, lab systems, special purpose & custom systems).
Providing consulting in the areas of Regulatory Affairs, Quality Assurance, and Governance/Risk/Compliance to domestic and international clients in regulated industries, primarily in Medical Devices, Life Sciences, and Healthcare.
Consult and support clients in analysis, definition, implementation, improvement, supervision and enforcement of quality and regulatory (e.g. QSR/GxP, HIPAA/HITECH, EHR) compliance, operational safety policies, data security policies, definition, review, and improvement of the process landscape, and alignment of processes to business.
Sample Consulting Assignment:
Subject Matter: Quality Assurance / Regulatory Compliance Role: Quality & RA Manager
Industry: Medical Devices
Period: 2014/08 to 2015-01
References: 2 – 3, upon request
Supported several R&D projects (in-house und OEM) as RA and QM subject matter expert: lab analytics instruments such as readers, washers, multi-mode readers with various hardware modules/ operation modes/ assay configurations for optical detection (Luminescence, Absorbance, Fluorescence, AlphaScreen/AlphaLISA, etc.)
Provided advisory consulting as RA subject matter expert in preparation of an FDA inspection
Sample Assignment (information on other assignments available upon request):
CoriMed, Inc. – USA
2002 – 2003
Project Manager & Technology Consultant (freelance)
Medical IT / Healthcare
Consulting, planning and pre-test implementation in a large-scale data center consolidation project. Consolidation of a Windows 2000 TS / Citrix MetaFrame environment of about 80 servers of a mixed standalone / failover / cluster configuration running Windows 2000 Advanced Server + Terminal Services, Citrix MetaFrame 1.8, NFuse, SQL Server, Exchange, into four IBM x/440 machines running VMware ESX Server. In parallel, a smooth migration of the SQL Server / Exchange environment towards an Open Source solution (Linux / IMAP / PostgreSQL), and from MS Office to an OpenOffice environment has been prepared. Integration of various UNIX-based medical applications and medical workstations (Solaris, AIX, HP-UX), and designing a connector architecture to an SAP (IS-H/Med) back-end system.
Technical project management including planning, organizing, and supervising the complete 510k & GxP compliant documentation process; working closely with clinical clients on implementation, usability, and compliance issues.
Consulting and support in the systems & operating environment analysis, and in writing development and systems documentation, such as: Proof of Concept Whitepaper, Requirements Specification, Design Specification, System Engineering Specification, Integrations Testing Whitepaper, Testing Manual, Migrations Testing Whitepaper, Migration Manual, System Failure & Disaster Recovery Whitepaper, Operating Manual.
Designed upgrade & replacement roadmap, cost analysis & control (TCO calculation), and budgeting Successfully completed the migration project on time, on scope, on budget
Development of a Medical Imaging (PACS) Online Archive. Planning, design and implement- ation of a hardware & software reference platform for a leading-edge, cost efficient digital online archiving system to store medical images (PACS), based on off-the-shelf Intel x86 Hardware and Windows NT, with standard network connection to large-scale medical imaging systems (Siemens Coroscope/ Bicor/ Polytron etc.) and real-time review devices (ACOM.M/.B/.PC), clinical data sources (HIS/RIS), clinical workstations, and clinical administrative back-end systems (IS-H/Med) via DICOM/HL7-driven communication.
WORK PERMIT & CITIZENSHIP INFORMATION
BRINGING IN-DEPTH EXPERTISE IN
Digital Transformation / Digital Business
COMPREHENSIVE EXPERIENCE IN
All services are available either on an FTE or fixed price basis. Please contact me for details and available options.
Average skill with various scripting languages such as Bash, Perl, PHP, AppleScript. A little Python and Swift.
!!! PLEASE NOTE: I AM NOT A SOFTWARE DEVELOPER !!!
Experience with enterprise systems of various vendors, e.g. IBM, Sun, Fujitsu, Dell, EMC, etc.
Experience with various industrial controller families, e.g. Siemens S7, Rockwell, Allen-Bradley, GE.
Experience with IoT controller plattforms (primarily Raspberry Pi).
Life Sciences / Biotech
Aerospace & Defense
Oil / Gas / Power / Utilities
Railway / Public Transport
EXCLUDED (I do NOT wish to work in these industries):
Finance (Banking / Insurance)
Governmental / Public Administration (except for Public Healthcare)