Chan Wing Shan Sally, MBA, RAC, RCC

Experience

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  Groupe Casino

  Sept 2008 - Aug 2011

  Quality Assistant

  - Household appliances- ISO 9001 standard- Make sure products follow EN and IEC standards- Comment on inspection reports and lab reports on failure points to monitor rework process- Project Management

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  Supergo Company Limited

  Sept 2011 - May 2012

  Data Analyst

  - Skin care products, wholesale and retail- Design and create data analysis reports using Excel- Analysis of sales data and forecast the future sales trend- Manage data in ERP system, inventory monitoring

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  Advanced MP Technology Limited

  Aug 2012 - Aug 2013

  Data and Market Analyst

  - Electronics trading- Create business opportunity from buy and sell sides- Market trend analysis, competitor analysis- Sales revenue and particular electronics parts analysis using Excel- Evaluation of potential customers- ERP system for data extraction

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  HELIOS Spital Überlingen GmbH

  Apr 2015 - Jul 2015

  Internship in Neuromonitoring

  - Signal monitoring of Continuous and Intermittent Intraoperative Neuromonitoring during thyroid surgeries (Dr. Langer Medical, Avalanche Software)- Inform surgeons about nerve signal properties- Assist in surgeries directly on patient- Documentation of nerve signals (Recurrent Laryngeal, Vagus and Superior Laryngeal Nerves) - Conduct animal experiments in the laboratory- Literature research and summary table

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  Aesculap AG

  Sept 2015 - Feb 2016

  Master Thesis in Navigation department for Orthopedics Implant Surgery

  Title: Facilitate workflow procedure in OR by using OCR recognition in Android operating system for surgical instruments- Programming in Java in Android Studio for Android application- Use of OpenCV for image processing- OCR recognition of Aesculap instrument codes in implant system

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  Börm Bruckmeier Verlag

  Nov 2016 - Dec 2017

  QMS Implementation Manager

  - Clinical Decision Support System (CDSS)- Preparation of TÜV audit for the first CE mark- Finializing SOPs, improving Document Control System, HR lifecycle, training system implemetation, Quality Management Handbook- ISO 13485:2016, ISO 14971:2012, IEC 62304:2006- MDD 93/42/EEC

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  Ethicon, Inc.

  Jan 2018 - Dec 2019

  Regulatory Affairs Specialist - EU Strategy
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  Ypsomed AG

  Jan 2020 - Sept 2024

  Regulatory Affairs Manager - Digital

  - Connected Devices- EU, US, China

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  Flowbone SA

  Dec 2024 - now

  Regulatory Affairs Manager

  - New Product Development - Orthopedics Innovation - US 510(k) Submission Lead