Veronique Smith Email & Phone Number

Charlotte, North Carolina, Us

Reporting to the Senior VP Quality & Regulatory, lead a regulatory team of 110 to ensure continued market access globally and registration of new products.

Princeton, New Jersey, Us

Reporting 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.

Princeton, New Jersey, Us

Reporting 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.

San Antonio, Tx, Us

Lead 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

San Antonio, Tx, Us

Lead 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

San Antonio, Tx, Us

Manage 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)

San Antonio, Tx, Us

Responsible 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

Wayne, Pa, Us

Functions: 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.

Irvine, California, Us

Functions: 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.

Dublin, Coolock, Ie

Functions: 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.

Dublin, Coolock, Ie

Functions: 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.