Sharon Lambert Email and Phone Number
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Sharon Lambert is a Regulatory Affairs Manager at Becton Dickinson at Becton Dickinson. She possess expertise in formulation, capa, sop, regulatory affairs, quality system and 35 more skills.
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Regulatory Affairs ManagerBecton Dickinson Nov 2019 - PresentManage a group of regulatory specialists ranging in experience from 2 months to 2 years. Maintain various documents for multiple franchises which include: MDD Tech Files and certificate renewals, prepare notifications of change to notified body and audit responses. Review and approve technical documentation including change notices, regulatory assessments of junior RA, PSUR, CER, PMS, risk documents, among others. Provide labeling and ad/promo review for franchise. -
Senior Regulatory Affairs SpecialistCr Bard Nov 2018 - Nov 2019Murray Hill, New Jersey, UsResponsible for regulatory strategies, assessments and guidance for new product development and sustaining engineering. Author of design dossiers, significant change submissions, post market surveillance, literature and labeling review, 510(k) submission and follow up. Manage junior staff directly involved with sustaining engineering assessments and labeling review. Maintenance of Tech File and audit preparation. -
Regulatory Affairs Specialist IiCr Bard Mar 2014 - Nov 2018Murray Hill, New Jersey, UsResponsible for regulatory strategies, assessments and guidance for new product development and sustaining engineering. Author of design dossiers, significant change submissions, post market surveillance, literature and labeling review, 510(k) submission and follow up. Mentor / management junior staff. Maintenance of Tech File and audit preparation.
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Regulatory Affairs SpecialistCiba Vision May 2009 - Mar 2014Duluth, Ga, UsResponsible for various duties including Health Canada and US product support, re-registration and change control determinations / assessments. Liaison for change control for devices (Class II and III devices) and DIN (Health Canada drug) products. Labeling review. Authored & reviewed Product Safety Update Reports, Risk Assessments per ISO 14971, non-filing decision papers for change control, strategy (US & global) for change assessments & new product development, PMA (Class III device) supplements & notices, re-registrationof drug and device products and site registrations with Health Canada. Collaboration with cross-functional and global teams. -
Scientist / Group LeaderCiba Vision Jun 1987 - Jun 2009Duluth, Ga, Us20 years experience in Microbiology, disinfection efficacy (especially as related to contact lens field). Have become increasingly more involved with quality initiatives within R&D micro and broader (i.e., global NCR / CAPA system, Trackwise). Have lead international teams in method transfer and problem solving issues. Earned Green Belt in Six Sigma 2008 and gained experience with MINITAB in reducing process variability. Vast knowledge of EXCEL. RAC-certified in 2001 and currently re-certified. Member of ASQ. Recipient of multiple Distinguished Performer Awards (peer & management nominations). Developed CAPA Training Booklet and trained 3 departments after receipt of Train the Trainer. Developed new microbiological QC tests from R&D and transferred to production site utilizing Green Belt skills. Developed QC system (including data entry forms) to reduce audit findings within microbiolgy dept.
Sharon Lambert Skills
Sharon Lambert Education Details
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North Carolina State University -
Rac Certified 2001
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Southeast Guilford High SchoolTechnological Animal Science
Frequently Asked Questions about Sharon Lambert
What company does Sharon Lambert work for?
Sharon Lambert works for Becton Dickinson
What is Sharon Lambert's role at the current company?
Sharon Lambert's current role is Regulatory Affairs Manager at Becton Dickinson.
What is Sharon Lambert's email address?
Sharon Lambert's email address is sh****@****ard.com
What is Sharon Lambert's direct phone number?
Sharon Lambert's direct phone number is (678)-415*****
What schools did Sharon Lambert attend?
Sharon Lambert attended North Carolina State University, Rac Certified 2001, Southeast Guilford High School.
What skills is Sharon Lambert known for?
Sharon Lambert has skills like Formulation, Capa, Sop, Regulatory Affairs, Quality System, Change Control, Six Sigma, Medical Devices, R&d, Fda, Glp, Gmp.
Who are Sharon Lambert's colleagues?
Sharon Lambert's colleagues are Sylvie Van Ooteghem, Eric Linder, Kelly Nocitra Mba, Msn, Rn, 陈琴琴, Javier Rivera, Kayla Van Benten, Bassirou Dieng.
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