Veronique Smith Email and Phone Number
York, Pennsylvania
Veronique Smith's Location
Austin, Texas, United States, United States
Veronique Smith's Contact Details
Veronique Smith work email
- Valid
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Veronique Smith personal email
n/a
Veronique Smith phone numbers
About Veronique Smith
Accomplished and results-oriented Regulatory Affairs leader with 20+ years of progressive experience executing on high priority registration projects and leading teams to approval of US, EU, and worldwide registrations of medical devices to support geographical expansion. Known for learning agility and expert proficiency in Regulatory Affairs and Regulatory Compliance and for building high functioning regulatory teams.
Veronique Smith's Current Company Details
Dentsply Sirona
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Vice President, Regulatory Affairs, Dentsply Sirona
York, Pennsylvania
- Website:
- dentsplysirona.com
- Employees:
- 10
Veronique Smith Work Experience Details
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Vice President Regulatory AffairsDentsply Sirona Jan 2024 - PresentCharlotte, North Carolina, UsReporting to the Senior VP Quality & Regulatory, lead a regulatory team of 110 to ensure continued market access globally and registration of new products.
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Vice President, Regulatory Affairs, Codman Specialty SurgicalIntegra Lifesciences Sep 2019 - Jan 2024Princeton, New Jersey, UsReporting to the President, Codman Specialty Surgical, lead a team of 22 members to develop and execute on US and EU (CE marking) regulatory strategies. Lead the work required for the EU MDR applications for the Codman Specialty Surgical Division, lead 510k submissions/clearances and provide guidance for OUS registrations to ensure a global approach to new product development projects and to significant changes of already registered medical devices. -
Vice President International Regulatory AffairsIntegra Lifesciences Oct 2015 - Aug 2019Princeton, New Jersey, UsReporting to the President of International, led a team of 20 members to develop and execute regulatory strategies for all markets outside of the US and Europe. Managed key international registrations, including registration of DuraGen Dural Regeneration Matrix in Japan, the first and only non-autologous collagen xenograft approved for use as a dural substitute in Japan. Stabilized team who had a high turnover rate and improved engagement. Led the Regulatory Affairs Work Stream for the integration of the Codman Neurosurgery business acquired by Integra in October 2017 from Johnson & Johnson. Managed transfer of registrations in over 80 countries to Integra in country legal entities, in country care takers, or distributors, as appropriate. Led discussions with BSI and Johnson & Johnson for legal manufacturer transfers and manufacturing site transfers, laid out and executed on the regulatory plan to manage these changes globally.
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Senior Director, Regulatory Affairs And Clinical AffairsKci Medical May 2012 - Oct 2015San Antonio, Tx, UsLead the KCI global regulatory affairs staff for registration of new products, expanded indications, design changes and registration renewals (5 direct reports, 8 total employees). •70 regulatory submissions in 2012 (including five 510k submissions), 100 submissions for 2013 •Lead audits of EU technical files (Class IIb and Class III products), audits of ARTG entries, and Canadian audits of medical device licenses (obtained a Canadian medical license in 24h and prevented issuance of a non-conformity during audit of registered establishment)•Responsible for KCI’s FDA listings and registrations•Manage shipment authorization of all KCI products to authorized countries (over 100 products in 80 countries)•Liaise with FDA, Notified Body, TGA, Health Canada for product submissions/registrations•Review labeling and advertising/promotion materials•Manage re-registrations/product changes due to buy-out of legal manufacturer facility and manufacturing transfers from Mexico to Ireland•Oversee the KCI Clinical Compliance program for clinical trials•Successfully transitioned regulatory team member to ArjoHuntleigh’s Regulatory Affairs team after buy out of KCI’s beds/mattresses business in November 2012 -
Director, International Regulatory AffairsKci Medical May 2010 - May 2012San Antonio, Tx, UsLead the international Regulatory Affairs group (4 direct reports) and develop employees in knowledge of US and international regulations and requirements for KCI’s wound products and beds/mattresses divisions. •Provide guidance to KCI’s design teams and direct reports regarding US and international regulatory requirements, upcoming changes in regulations and regulatory pathways (5 new product launches: VAC Via, Prevena, VAC Ulta, Zuma lifts and Skin IQ bed cover)•Attended successful SFDA panel meeting in China to support registration of KCI’s VAC System•Registered KCI’s Negative Pressure Wound Therapy systems in emerging markets: Brazil, Russia, India, Mexico, Korea and China
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Senior Manager, Regulatory Affairs (August 2009 - May 2010) - Manager (May 2008 - August 2009)Kci Medical May 2008 - May 2010San Antonio, Tx, UsManage 2 regulatory affairs specialists’ day to day activities in supporting expansion of KCI in core geographies.•Established process for authorizing shipment of all KCI products•Established procedures for creation of technical files, review of changes and effects of the changes on registrations, regulatory release of product shipments after final design control deliverable, regulatory review of labeling, Canadian device license applications•Lead and develop employees in knowledge of global regulations and requirements. Support innovation teams in launch of new products in US, EU, Canada, Australia, Mexico, Brazil, India, China, Singapore, Korea (ActiVAC and InfoVAC systems)
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Senior Regulatory Affairs SpecialistKci Medical May 2006 - May 2008San Antonio, Tx, UsResponsible for KCI’s international registrations.•Develop international strategies/plans for all KCI products•Prepare and file all international regulatory submissions for KCI’s medical devices including technical files for CE marking for class I, IIa and IIb devices•Develop system for tracking registration applications, approvals, and renewals•Assist with Notified Body audits•Review labelling for compliance with US and international requirements •Manage FDA’s device listings and establishment registrations KCI•Assist in preparing 510(k) submissions
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Senior Regulatory Affairs SpecialistTeleflex Medical Apr 2005 - May 2006Wayne, Pa, UsFunctions: Prepare international regulatory submissions for class I, II and III medical devices (ex: surgical instruments, nebulizers, cardiac pacing wires, and absorbable cardiovascular sutures) for China, Taiwan, Mexico, and Brazil. Prepare technical files and design dossiers for CE marking. Assist with notified body audits. Participate in design teams and develop global regulatory strategies/plans. Review labels and advertisement for compliance with international requirements. Provide guidance to less seasoned regulatory staff. -
Senior Analyst, Global Regulatory Submissions (International Ra Analyst Aug 2000 - Sept 2003)Mentor Worldwide Llc Aug 2000 - Mar 2005Irvine, California, UsFunctions: Prepare all international regulatory submissions for Mentor’s breast implants, penile implants, urology products and healthcare products. Serve as the regulatory contact on various project teams to assist the marketing, R&D and manufacturing groups with regulatory issues during product design and prior to product release. Assist the corporation in being pro-active to regulatory changes in the international arena. Assist the Program Director of Regulatory Affairs with CE marking, labeling review, interpretation of regulations, and review of technical files. -
Clinical Research SupervisorAllergan Jan 2000 - Aug 2000Dublin, Coolock, IeFunctions: Directly supervise 14 data entry assistants. Oversee all aspects of database entry for McGhan’s clinical studies. Responsible for the timely and accurate entry of data points. Develop and implement procedures for the department and administer large projects. Ensure compliance to GMPs and FDA requirements. -
Research AssociateAllergan Sep 1998 - Jan 2000Dublin, Coolock, IeFunctions: Contact investigators for enrollment, maintenance, and resolution of issues for clinical studies. Complete Case Report Form corrections to ensure accuracy of clinical data. Perform audits of files and database information. Responsible for processing incentive payments to patients and investigators, patient transfers, visit compliance and preparation of CRAs’ monitoring visits. Responsible for autoimmune/connective tissue disease reports and IRB coordination. Assist with clinical portion of PMA submission for saline-filled breast implants.
Veronique Smith Skills
Regulatory Affairs
Medical Devices
Iso 13485
Regulatory Submissions
Fda
Clinical Trials
Cross Functional Team Leadership
Quality System
Design Control
Gmp
Ce Marking
Iso 14971
Product Launch
Product Development
Validation
Commercialization
R&d
V&v
Clinical Research
Capa
Iso
Veronique Smith Education Details
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Uc Santa BarbaraB.A. Biological Sciences
Frequently Asked Questions about Veronique Smith
What company does Veronique Smith work for?
Veronique Smith works for Dentsply Sirona
What is Veronique Smith's role at the current company?
Veronique Smith's current role is Vice President, Regulatory Affairs, Dentsply Sirona.
What is Veronique Smith's email address?
Veronique Smith's email address is ve****@****ci1.com
What is Veronique Smith's direct phone number?
Veronique Smith's direct phone number is (210)-524*****
What schools did Veronique Smith attend?
Veronique Smith attended Uc Santa Barbara.
What skills is Veronique Smith known for?
Veronique Smith has skills like Regulatory Affairs, Medical Devices, Iso 13485, Regulatory Submissions, Fda, Clinical Trials, Cross Functional Team Leadership, Quality System, Design Control, Gmp, Ce Marking, Iso 14971.
Who are Veronique Smith's colleagues?
Veronique Smith's colleagues are Reed Schmitt, Gemma González Gallego, Eckhardt Roy, Kelly Bauman, Nick Michalko, Ginger Greer, Kim Straatmann.
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