Courtney Clark
About
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Sr. Director, Regulatory Affairs, Solventum
Irvine, California, United States
Résumé
Jobs
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Sr. Director, Regulatory AffairsSolventumJul 2023 - Current (3 years 4 months)Lead regulatory teams in US, EU and LATAM that support $1.3B business for Dental Solutions at Solventum. Includes global submissions and strategies (Americas, EU, EMEA and APAC), rebranding activities, M&A, new product development, process improvements and AI initiatives across the global regulatory affairs department.- Sr. Director, Corporate Regulatory AffairsDentsply SironaJun 2021 - Jul 2023 (2 years 2 months)
- Program Director, Global Regulatory AffairsAdvanced Sterilization Products ASPNov 2019 - Jun 2021 (1 year 8 months)Managed global divestiture from J&J to Fortive Corp. for regulatory affairs and labeling. Oversaw global labeling department.
- Sr. Manager, Regulatory AffairsEdwards LifesciencesSep 2016 - Nov 2019 (3 years 3 months)Transcatheter cardiovascular implants, critical care hemodynamic monitoring devices, AI, software
510(k), PMA, IDE, international clinical studies, Australia, Canada, De Novo, EU MDR technical documentation, direct reports - Manager, Regulatory Affairs, Transcatheter ValvesEdwards LifesciencesJan 2016 - Sep 2016 (9 months)Early feasibility studies, US, Canada and EU; regulatory strategies for Class III Tricuspid Repair System
- Corporate Regulatory Affairs Manager, SubmissionsKaVo KerrOct 2013 - Jan 2016 (2 years 4 months)Broad portfolio of dental equipment and consumable operating companies under Danaher Corporation
US 510(k)s, Canada licenses and submissions, STED, EPA, corporate regulatory strategy, direct reports - Quality and Regulatory ManagerDentsplyMay 2013 - Oct 2013 (6 months)Global dental device company, Class I - III device and pharmaceuticals, capital equipment
Global product registrations, 510(k)s, quality system management, design dossiers, EU technical files, PMA supplements, clinical studies, direct reports - Sr. Regulatory Affairs SpecialistDentsplyOct 2010 - Apr 2013 (2 years 7 months)Global product registrations, 510(k)s, EU technical files, design dossiers, Class I, II, III devices, software, infection control, pharma. Managed internal audit program, supplier audit program, training program, QC lab, clinical trials and direct reports.
- CQuality Systems and Regulatory SpecialistCohera MedicalFeb 2008 - Oct 2010 (2 years 9 months)Startup medical device company specializing in a Class III implant, novel surgical adhesive
Author/implement full ISO 13485/GMP quality management system. Authored documentation/submission for EU clinical study and US IDE. Also managed all aspect of QMS, performed supplier and internal audits. - Quality Assurance SpecialistKing PharmaceuticalsJun 2005 - Feb 2008 (2 years 9 months)Sterile manufacturing plant producing injectable penicillin
Quality sign off on batch records for product release, monitored manufacturing and packaging activities, performed environmental monitoring of clean rooms. - Technical WriterKing PharmaceuticalsJun 2004 - Jun 2005 (1 year 1 month)Technical writer in the document control department; SOPs, change orders, test methods.
- Assistant ScientistPfizerJan 2003 - Jan 2004 (1 year 1 month)
- Quality Control Laboratory TechnicianBaxter BioscienceJan 2001
Education
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- BS, BiologyOakland UniversityJan 1998 - Jan 2001 (3 years 1 month)
- Associates, Liberal ArtsOakland Community CollegeJan 1995 - Jan 1998 (3 years 1 month)
- Master's degree program, Molecular GeneticsOakland University
Projects (professional or personal)
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Awards
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- IEmerging Leaders Program GraduateIssued by DentsplyNominated for, accepted into, and graduated from 2 year program for management training (Emerging Leaders) at DENTSPLY.
Publications
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- JEffectiveness of a calcium sodium phosphosilicate containing prophylaxis paste in reducing dentine hypersensitivity immeJournal of Clinical Periodontology AprAbstract
Aims
The aim of this single-site, randomized, controlled, double-blind, 3-arm parallel study was to determine the effectiveness of a prophylaxis paste containing 15% calcium sodium phosphosilicate (CSPS; NovaMin®) with and without fluoride in reducing dentine hypersensitivity immediately after a single application and 28 days following dental scaling and root planing.
Materials & Methods
Overall, 151 subjects were enrolled in this study. All subjects received a scaling and root planing procedure followed by a final prophylaxis step using one of three different prophylaxis pastes: Test-A (15% NovaMin® and NaF), Test-B (15% NovaMin®) and a control. Dentine hypersensitivity was assessed by tactile stimulus (Yeaple - ANUPRO Sensodyne Prophylaxis Paste with NovaMin for the Treatment of Dentin Hypersensitivity; a 4 Week Clinical StudyAmerican Journal of Dentistry OctABSTRACT: Purpose: The primary objective of this study was to compare the effectiveness of NUPRO Sensodyne Prophylaxis Paste with NovaMin, with and without fluoride, to a standard prophylaxis paste without fluoride (control) in reducing dentin hypersensitivity immediately after a single application following dental scaling and root planing. The secondary objective was to compare the duration of sensitivity relief up to 28 days after a single application of the NUPRO pastes with NovaMin compared to the control paste. Methods: This was a randomized, single-center, controlled, threetreatment, parallel-group study. At baseline, tactile and air blast stimuli were administered and subjects were stratified according to their baseline air blast (Sc