Sha L. Email and Phone Number
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.
Biotronik
View- Website:
- biotronik.com
- Employees:
- 3647
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Clinical EvaluatorBiotronik Aug 2022 - PresentDistrict 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 -
MemberRegulatory Affairs Professionals Society (Raps) Jan 2022 - Present -
Medical Writer | ConsultantMd-Clinicals Sa Jan 2022 - Jul 2022Lonay, 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 -
Postdoctoral ResearcherUniversité De Lausanne Feb 2017 - Dec 2021Lausanne Area, Switzerland -
From Science To Pharma (Fstp)- Msl CertificateFrom Science To Pharma (Fstp) - Msl Global Online Training Jun 2020 - Jul 2020Lausanne, Vaud, SuisseCompleted 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 -
Postdoctoral ResearcherUniversité De Lausanne Aug 2015 - Jan 2016Switzerland -
Assistant Recherche DiplôméUnil - Université De Lausanne Aug 2010 - Jul 2015Under 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. -
Collaborateur ScientifiqueHeinrich-Heine-Universität Düsseldorf Nov 2009 - Jul 2010Düsseldorf Area, GermanyWorking 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. -
Collaborateur ScientifiqueUniversité Claude Bernard Lyon 1 Oct 2008 - Oct 2009Région De Lyon, FranceExplore the role of histamine in arousal regulation by using transgenetic mouse model. -
Doctor Of MedicineKunming Medical College Sep 2000 - Jul 2005Kunming City, ChinaTrained 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
Sha L. Education Details
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Ai In Healthcare -
5.5/6 -
Science / Recherche Clinique En Laboratoire Médical Et Professions Paramédicales -
Management Of Biotech, Medtech & Pharma Ventures -
Life Science -
Medicine
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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