Michael Reiff partly available

Michael Reiff

Program & Project / QA/RA / R&D / Digital Transformation / Requirements Manager

partly available
Profileimage by Michael Reiff Program & Project / QA/RA / R&D / Digital Transformation / Requirements Manager from Baar
  • 6340 Baar Freelancer in
  • Graduation: B.A. (Philosophy, Political Science, Computer Science)
  • Hourly-/Daily rates:
  • Languages: German (Native or Bilingual) | English (Native or Bilingual) | Russian (Elementary) | Spanish (Elementary)
  • Last update: 01.09.2021
KEYWORDS
PROFILE PICTURE
Profileimage by Michael Reiff Program & Project / QA/RA / R&D / Digital Transformation / Requirements Manager from Baar
ATTACHMENTS
SKILLS
Specializing in Regulated Industries (Medical Devices, Life Sciences) in the fields of

Program & (Multi-)Project Management
Quality & Regulatory Affairs Management

Requirements Management
Digital Transformation Consulting & Management
Organizational Excellence, Governance/Risk/Compliance, Transition Management
Enterprise IT Management for Regulated Industries / Healthcare



Quality & Regulatory Affairs Management:
  • Regulatory expertise for: USA (FDA), Canada (Health Canada), European Union (Notified Bodies), China (CFDA), Japan (PMDA), Brazil (ANVISA), Mexico (COFEPRIS), Australia (TGA)
  • 21 CFR Part 820 (QSR, cGMP, PHA, FMEA, CAPA, HHA, PDCA cycle)
  • 21 CFR Part 11 (Electronic Records and Electronic Signatures)
  • FDA Q9 QRM (PHA, FMEA, FMECA, FTA, HACCP, HAZOP)
  • 21 CFR Part 808 (Device Exemptions)
  • 21 CFR Part 812 (Clinical Investigations)
  • GAMP5, Computer Systems Validation (CSV), SDLC, SOPs
  • Validation Process Management (Project Plan, VMP, Design Transfer, DQ, PQ, IQ, OQ)
  • Validation Master Plan (VMP) creation, maintenance, management
  • System Reliability & Risk Analysis (Design/Functional/Process FMEA & FMECA)
  • Design Transfer QA, Management, Execution, QA-support for Operations setup
  • 510(k) Clearance (Pre-market Notification)
  • ISO 9001 (QS continuous improvement process)
  • ISO 13485 (EU/ECC QSR)
  • ISO 14971 (Risk Management for Medical Devices)
  • ISO 62304 (Medical Device Software SLC)
  • ISO 62366 (Application of usability engineering to medical devices)
  • MDD 93/42/EEC (EU Medical Device Directive)
  • IVD 98/79/EC (EU In Vitro Diagnostic Medical Device Directive)
  • AIMDD 90/385/EEC (EU Active Implantable Medical Device Directive)
  • EU Medical Products Application (EudraLex Vol. 2)
  • EU Medical Products Guidelines (EudraLex Vol. 3)
  • EU GMP (EudraLex Vol. 4)
  • EU Clinical Trials (EudraLex Vol. 10)
  • ICH Q7 (GMP), ICH Q9 (QRM)
  • EU Machinery Directive (2006/42/EC) (application to, and compliance of, machinery which is part of, used by, or together with medical devices, e.g. automated/robotic lab systems)
  • Environmental Compliance of (medical) devices: RoHS (2002/95/EC), REACH (EC No 1907/2006), WEEE (2002/96/EC)
  • Production line inspection & validation (VP, DQ, PQ, IQ, OQ)
  • Planning, inspection, validation of CIP/WIP/SIP procedures, qualification (QC) of equipment
  • HIS, RIS, Medical Imaging / PACS (systems, architecture, implementation)
  • Laboratory Information & Management Systems (e.g. AQ Manager, CareLIMS, LabWare, SLIMS)
  • Clinical IT Infrastructure (architecture, design, implementation, operation, continuity)
  • Clinical IT Security, Threat & Vulnerability Assessment/ Analysis/ Remediation
  • Clinical ERP (IS/H, i.s.h.med)
  • Healthcare IT Standards (DICOM, HL-7, MEDICOM, IHE, ACC, NEMA, RSNA, HIMSS, etc.)
  • Inter-/cross-modality communication & integration (CR, CT, DX, MR, NM, PT, PX, ST, US, XA, etc.)
  • Clinical Workflows
  • Clinical Trials (CTMS, EHR4CR, ICE), Document Management (eCTD), Data Archiving (cDWH)
  • Device ergonomics & UX/usability of clinical applications
  • EHR & Health Information Privacy (HIPAA, HITECH Act, Directive 2011/24/EU)
  • Business Continuity, Disaster Recovery Planning, SOX-404 Compliance in the Healthcare industry

Organizational Excellence, Governance, Strategy, Transition Management:
  • QA/RA Strategy, Implementation, Execution
  • Process Alignment & Coherence
  • Business Continuity
  • Disaster Recovery Planning
  • Enterprise Architecture (TOGAF, CoBIT, CMMI, ITIL)

International Program & Multi-Project Management:
  • Agile (DSDM, Scrum, general theory & application of agile methodologies)
  • PMI/PMBoK
  • Classic (V, Waterfall)

Enterprise IT Management for Regulated Industries / Healthcare:
  • IT Management for Production/Operations & Enterprise Platforms
  • Business Intelligence
  • Compliant Document Management Systems (EHR, HIPAA)
  • Compliant Workflow Management Systems
PROJECT HISTORY
GLOBAL PROGRAM MANAGER ― CONNECTIVITY SOLUTIONS
Belimed - Zug, Switzerland - 2016-2018
Global lead of the Connectivity Solutions program, which is Belimed’s effort to bundle all ideas, resources, assets, R&D activities, and client solutions relating
to the company’s digital transformation under a joint oversight and governance body responsible for coordinated planning, management, and project execution, in order to maximize efficiency and synergies, and to minimize overhead and duplicate work.
The CS Program serves to align Belimed’s digital transformation efforts with the digital strategy of corporate group management. It is an expression of the company’s belief that the future of healthcare in general, and medical devices in particular, is digital and connected, and emphasizes Belimed’s commitment to be at the forefront of the digital revolution and a leader in the digital transformation in healthcare.

HEAD OF ORGANIZATIONAL EXCELLENCE
CynetiX Technology Consulting GmbH - Switzerland - 2008-2016
Head of Organizational Excellence: Quality & Risk Management, Regulatory Affairs, Governance, Compliance. Program Manager R&D Healthcare. Program Manager R&D Aerospace & Defense. Corporate IT Strategy & Governance (ad interim CIO).

STRATEGY, GOVERNANCE & TECHNOLOGY CONSULTANT
Various Clients - Europe & USA - 2002-2007
Freelance strategy, governance, technology, and security consultant at the corporate/enterprise level for various clients.

MENTOR/COACH
IBM - Germany - 2001-2002

PROJECT MANAGER
Sun Microsystems - San Diego, CA, USA - 2000
Project Manager for planning and implementation of a compute cluster at UCSD Scripps Institution.

PROJECT, QUALITY & RA MANAGER
Siemens Healthcare - Hoffman Estates (USA) - 1991- 1999
Project & Quality Manager in a multi-million, global HIS/RIS (Angio/X-ray PACS) R&D project.

TECHNOLOGY SPECIALIST
German Armed Forces - Germany & USA - 1989-1991
TIME AND SPATIAL FLEXIBILITY
Availability in D-A-CH:
  • 100% REMOTE ONLY (not only during the time of the Corona-virus induced travel & contact restrictions but in general as well)

Availablity internationally:
  • 100% REMOTE ONLY (not only during the time of the Corona-virus induced travel & contact restrictions but in general as well)
  • English-speaking countries & regions ONLY
OTHER
My resume and letters of reference are available for download on my LinkedIn page.
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