Sha L.

Sha L. Email and Phone Number

Clinical evaluation | Medical Writer | Regulatory Affairs | Management of Clinical Trials | Consultant | Neuroscientist @ BIOTRONIK
berlin, berlin, germany
Sha L.'s Location
Zürich Metropolitan Area, Switzerland
About Sha L.

At BIOTRONIK, my mission is to advance the vascular intervention field through meticulous clinical evaluation and regulatory strategy for medical devices. My expertise in regulatory affairs, honed at both BIOTRONIK and MD-CLINICALS SA, enables me to navigate the complexities of global market access, ensuring that products meet stringent health authority standards.My role as a Clinical Evaluator involves formulating literature search strategies, authoring clinical documents, and coordinating with cross-functional teams to support product development and risk analysis. With a focus on EU MDR compliance, I contribute to shaping clinical strategies that prioritize patient safety and improved outcomes.

Sha L.'s Current Company Details
BIOTRONIK

Biotronik

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Clinical evaluation | Medical Writer | Regulatory Affairs | Management of Clinical Trials | Consultant | Neuroscientist
berlin, berlin, germany
Website:
biotronik.com
Employees:
3647
Sha L. Work Experience Details
  • Biotronik
    Clinical Evaluator
    Biotronik Aug 2022 - Present
    District De Bülach, Zurich, Suisse
    -Performing clinical evaluation for coronary or peripheral vascular intervention devices (Initial submission or annually updating) under EU MDR 745/2017-Formulating Literature search keywords to conduct literature search and appraisal -Planning, authoring, reviewing clinical documentation for submission to Notified bodies (e.g: BSI)-Supporting and reviewing clinical documentation for submission to NMPA, FDA and Health Canada-Making strategy and preparing responses to… Show more -Performing clinical evaluation for coronary or peripheral vascular intervention devices (Initial submission or annually updating) under EU MDR 745/2017-Formulating Literature search keywords to conduct literature search and appraisal -Planning, authoring, reviewing clinical documentation for submission to Notified bodies (e.g: BSI)-Supporting and reviewing clinical documentation for submission to NMPA, FDA and Health Canada-Making strategy and preparing responses to Health Authority questions during global market access and maintenance-Supporting development of de novo products to define clinical strategy (pre-market and post-market follow up)-Supporting product and process risk analysis -Coordinating with external sources (e.g: CRO) and reviewing related documentations for submission Show less
  • Regulatory Affairs Professionals Society (Raps)
    Member
    Regulatory Affairs Professionals Society (Raps) Jan 2022 - Present
  • Md-Clinicals Sa
    Medical Writer | Consultant
    Md-Clinicals Sa Jan 2022 - Jul 2022
    Lonay, Vaud, Switzerland
    • Develop new and update existing Clinical Evaluation Reports (CER), Clinical Evaluation Plan (CEP), Risk Benefit Analysis (RBA), Post-market Clinical Follow-up (PMCF) Plan/Report in compliance with MDR• Author or review state-of-the-art (SOTA) literature documents • Collaborate with multiple stake holders/cross functional teams such as Medical Affairs, Systems Engineers, Regulatory, and Quality personnel
  • Université De Lausanne
    Postdoctoral Researcher
    Université De Lausanne Feb 2017 - Dec 2021
    Lausanne Area, Switzerland
  • From Science To Pharma (Fstp) - Msl Global Online Training
    From Science To Pharma (Fstp)- Msl Certificate
    From Science To Pharma (Fstp) - Msl Global Online Training Jun 2020 - Jul 2020
    Lausanne, Vaud, Suisse
    Completed a comprehensive online MSL training course conducted by Dr. Martijn Bijker and his team where I gained a thorough understanding of:- Pharmaceutical Industry- The responsibilities and day-to-day activities of an MSL- The objective of an MSL- How the MSL interacts with KOLs- The product life cycle (PLC) of a drug and the role of the MSL during the different stages of the PLC- The compliance code of conduct
  • Université De Lausanne
    Postdoctoral Researcher
    Université De Lausanne Aug 2015 - Jan 2016
    Switzerland
  • Unil - Université De Lausanne
    Assistant Recherche Diplômé
    Unil - Université De Lausanne Aug 2010 - Jul 2015
    Under supervision of Prof. Mehdi Tafti and Dr. Anne Vassalli to find out the functions of Hypocretin (Orexin) receptors 1 & 2 signaling in neural circuits regulating arousal.
  • Heinrich-Heine-Universität Düsseldorf
    Collaborateur Scientifique
    Heinrich-Heine-Universität Düsseldorf Nov 2009 - Jul 2010
    Düsseldorf Area, Germany
    Working in the lab of Prof. Haas at Heinrich-Heine University in Düsseldorf Germany, to obtain systematically patch-clamp training to explore ursodeoxycholic acid (UDCA) in promoting wakefulness.
  • Université Claude Bernard Lyon 1
    Collaborateur Scientifique
    Université Claude Bernard Lyon 1 Oct 2008 - Oct 2009
    Région De Lyon, France
    Explore the role of histamine in arousal regulation by using transgenetic mouse model.
  • Kunming Medical College
    Doctor Of Medicine
    Kunming Medical College Sep 2000 - Jul 2005
    Kunming City, China
    Trained systematically as generalized medicine (4 years) and finished one year internship in all departments of First People's Hospital of Yunnan Province (Kunhua Hospital) in Kunming. In 2008, board certified generalized physician.

Sha L. Skills

Sciences De La Vie Immunohistochimie Statistiques Gestion De Projet Medical Writing Communication Regulatory Affairs Microscopie Biochimie Science Planification Des Affaires Recherche Clinique Anglais Neurosciences

Sha L. Education Details

Frequently Asked Questions about Sha L.

What company does Sha L. work for?

Sha L. works for Biotronik

What is Sha L.'s role at the current company?

Sha L.'s current role is Clinical evaluation | Medical Writer | Regulatory Affairs | Management of Clinical Trials | Consultant | Neuroscientist.

What schools did Sha L. attend?

Sha L. attended Mit Sloan Executive Education, Université De Genève, Université De Lausanne, Ecole Polytechnique Fédérale De Lausanne, Université De Lausanne, 中山大学, Kunming Medical College.

What skills is Sha L. known for?

Sha L. has skills like Sciences De La Vie, Immunohistochimie, Statistiques, Gestion De Projet, Medical Writing, Communication, Regulatory Affairs, Microscopie, Biochimie, Science, Planification Des Affaires, Recherche Clinique.

Who are Sha L.'s colleagues?

Sha L.'s colleagues are Ken Valikai, Halte Marie, Paola Napoli, Christoph Forkmann, Andreas Gute, Daniele Spinelli, Derek Hermes.

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