Sylvie Couderc Email and Phone Number
"The conductor of an orchestra doesn’t make a sound. He depends, for his power, on his ability to make other people powerful." (Benjamin Zander) As international regulatory affairs director, my role is quite similar: I align players across the entire organization to achieve compliance, build trust with conformity assessment bodies and secure/accelerate market access. In doing so, my 20+ year career has been about connecting the dots between constantly evolving regulations and their on-the-ground application, to facilitate company-wide synergies to...►Transition from EU MDD to EU MDR ► Obtain CE Certification and international approvals for new product launch ► Design actionable RA strategies ►Proactively mitigate business risks ► Manage change ► Influence early-stage innovation programs ► (and much more) ...at companies such as BD, Eli Lilly and Sanofi. More deeply, what really motivates me about my work is knowing that our combined efforts to manage such multi-layered regulatory complexity deliver safe medical devices that fulfill their mission of saving lives and improving healthcare outcomes.👉I am always keen to grow and nurture my network within medical devices, healthcare and pharma regulatory affairs, so please feel free to send me contact request here.
Sequel Med Tech
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International Senior Regulatory Affairs DirectorSequel Med Tech Mar 2024 - PresentManchester, Nh, Us -
International Regulatory Affairs Director, Medication Management SolutionsBd 2015 - Jan 2024Franklin Lakes, New Jersey, UsWith the acquisition of CareFusion in 2015, BD expanded its portfolio into infusion pumps, infusion sets, software as medical devices, and dispensing equipment. Joining this newly created BU, my main contributions were:✅ POST-ACQUISITION BU INTEGRATION Outlined and executed regulatory integration plan, consolidating team infrastructure to align product portfolios, gain worldwide approvals and produce revenue targets.✅ RA LEADERSHIP FOR SEVERAL PRODUCT PLATFORMS Managed RA teams in 5 countries; devised and led RA strategy and activities for all aspects of product lifecycle in partnership with business unit and regional leaders. ✅ EU MEDICAL DEVICE REGULATION (MDR) COMPLIANCE LEADERSHIP Drove remediation program for transitioning 5 CE certifications from MDD into MDR. ✅ RA STRATEGY FOR DRUG-DEVICE COMBINATION PRODUCTSAdvised RA strategy for new drug delivery systems at early stage of the innovation funnel. -
International Regulatory Affairs Leader, Diabetes CareBd 2014 - 2015Franklin Lakes, New Jersey, UsAs the international regulatory affairs leader my responsibilities expanded from my former position as EMEA RA manager to RA strategies for early stage innovation funnel in key target markets (EU, China, Japan and Brazil). Product scope included the core diabetes care portfolio as well as new diabetes delivery system, point of care diabetes monitoring (IVD), and diabetes apps. -
Regulatory Affairs Manager - Bd Medical Diabetes CareBd 2006 - 2014Franklin Lakes, New Jersey, UsIn this position, I managed RA for the EMEA region, supporting the diabetes care core portfolio including : • New registrations, renewals, amendments• Changes to regulations• Labeling approval• Promotional material review================================Scope & Impact:✅ Managed RA activities for +70 countries, including 6 CE certifications and European representative responsibilities✅ Set up and managed a small team of RA specialists✅ Established RA policies and processes for the department and EMEA region Product Life Cycle Management process✅ Coordinated activities in sync with EMEA leadership team, design center, manufacturing sites, local RA contacts, and cross-functional teams (e.g. marketing, R&D, quality, supply chain) -
Qa/Qc Team Leader For Api And ExcipientsEli Lilly And Company 2003 - 2006Indianapolis, Indiana, UsIn this position, I oversaw quality assurance / quality control systems and activities for active pharmaceutical ingredients (API) and excipients used at the manufacturing site for the formulation of parenteral drug products such as:• Insulin• Human growth hormone• Cytotoxics -
Regulatory Affairs Specialist, Parenteral Drug ProductsEli Lilly And Company 1998 - 2003Indianapolis, Indiana, UsAs an RA specialist, I oversaw relevant activities for 17 drug product presentations in +120 countries including the EU, the US and other worldwide markets, focusing on the chemical manufacturing and control (CM&C) part of the applications. -
Ra Coordinator, Recombinant Active Pharmaceutical Ingredient (Api) Registration FileSanofi Jun 1997 - Dec 1997Paris, France, FrAs RA coordinator, I authored the API section of the CM&C dossier (Chemistry, Manufacturing, and Controls) for a new recombinant drug product application in the EU and the US. -
Student Internship, Pharmacology ResearchSanofi Feb 1996 - Jul 1996Paris, France, Fr
Sylvie Couderc Education Details
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Institut D’Administration Des Entreprises (Iae) –Orléans (France).Management And Strategies In Healthcare Industry -
Université Paul Sabatier Toulouse IiiBiotechnologies Applied To Healthcare
Frequently Asked Questions about Sylvie Couderc
What company does Sylvie Couderc work for?
Sylvie Couderc works for Sequel Med Tech
What is Sylvie Couderc's role at the current company?
Sylvie Couderc's current role is International Regulatory Affairs Director: MedTech | Medical Devices | Drug-Device Combination Products ► Bridging cross-functional domains and cultures to promote and achieve regulatory compliance..
What schools did Sylvie Couderc attend?
Sylvie Couderc attended Institut D’administration Des Entreprises (Iae) –orléans (France)., Université Paul Sabatier Toulouse Iii.
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