Amber Stallings Email and Phone Number
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Amber Stallings personal email
Medical Device industry RA/QA professional with over eight years of experience in international quality compliance and global regulatory strategy. Effective understanding of domestic and international regulatory standards, guidelines, and requirements which include but are not limited to: ISO 13485:2016, ISO 14971:2019, EU MDR, 21 CFR Part 820, 21 CFR Part 876, MDSAP (medical device single audit program).Honors graduate with a Bachelor of Science in Nutrition.Experience Highlights:• International regulatory compliance - experience in markets including but not limited to: EU, China, Canada, Latin America, Central America, Japan, Australia, Middle East, Southeast Asia, Eastern Europe, India, United Kingdom, etc• Successful global registrations/premarket submissions - new product lines and/or entrance into new markets• Continued maintenance of international device registration approvals• CAPA system management - investigation, root cause determination, risk analysis, and effective monitoring• Complaint system management - investigation and root cause/hazard criticality analysis (ISO 14971:2019)• Management of MDR/Vigilance Reporting - Supporting a risk-based compliant approach with clear and effective written communication on behalf of the Company • Non-conformance investigation, defect analysis, and trending• Audits (MDSAP, FDA, EU MDR, competent authorities, notified body, internal, supplier) - Onsite and Remote• Proficiency in understanding and preparing technical documentation, in addition to providing competent authorities detailed analysis as required in support of device registration projects• Data analytics and preparation of ad-hoc reports for the purpose of commercialization history, to support adverse event, recall, and/or field safety corrective actions, MRB, and management review---> Nutrition and Lifestyle Goal-Oriented CoachingCertified in Coaching Psychology - Life UniversityContact: JumpintoNutrition@gmail.comRemote or In-Person - One-on-One or Group Settings- Lifestyle improvements- Goal identification & accountability training- Necessary diet changes following a life event- Recondition your view of food and food preparation- Catered support surrounding your unique needs, real life tactics for continued success
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Regulatory Affairs ConsultantAs Qms ConsultingWoodstock, Ga, Us
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Ra/Qa EngineerDornier Medtech Sep 2019 - PresentSingapore, Singapore, Sg- Regulatory Affairs: Independent support of global regulatory teams in renewing device registrations as well as preparing new device submissions within an identified market. Responsibilities include the review of technical information and preparation of required documentation (apostilled CFG’s, LOA, DoC, letters answering specific inquiries, etc). Maintenance of knowledge of evolving global regulatory requirements. - Complaint Handling: Independently responsible for all elements from intake to closure including adverse event reporting. Ensuring total compliance, effective and proactive investigations, thorough documentation, as well as timely completion. - CAPA System: Independently responsible for total system including investigation, root cause determination, risk analysis, action completion, and monitoring of effectiveness. - Direct support for all QMS (MDSAP, FDA, EU MDR) audits completed (notified body, competent authority, supplier, internal) including autonomous accountability for complaint system, CAPA’s, and NC close-out.- Maintenance of technical knowledge and review of Technical Files and Device/Design History Files for information relevant to international market submissions. - Creation of GTIN’s (UDI) for new products and maintenance of relevant FDA database (GUDID). - Annual preparation and presentation of management review data as related to responsible systems.Dornier MedTech America, located in Kennesaw, GA, is an MDSAP, EU MDR, and ISO 13485:2016 certified manufacturer. Dornier is a global market leader offering both urology and medical-aesthetic surgical lasers, lithotriptors, and urological devices. Dornier MedTech provided the industries first electroshock-wave lithotripsy device, ultimately revolutionizing the way kidney stones are treated worldwide.
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Nutrition And Gi Disorder SpecialistJump Into Nutrition Jan 2015 - PresentNutrition and Lifestyle Goal-Oriented CoachingRemote or In-Person - One-on-One or Group Settings - Single Event or Recurring Contact: JumpintoNutrition@gmail.comProviding goal identification, coaching, and accountability support – GI Disorder Expert- Experience hosting seminars focused on nutrition science and health awareness, designing effective resources, writing educational narrative, analysis of topical research and market trends. - Collaboration with nutrition professionals hosting community events.
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Qa/Ra Associate - Neomed, Inc.Avanos Medical Aug 2016 - Sep 2019Alpharetta, Georgia, Us[NeoMed, Inc. was fully acquired by Avanos, Inc. in July 2019.] ISO 13485:2016 and MDSAP certified, FDA regulated facility manufacturing enteral devices for NICU and pediatric patients.- Independently responsible for total complaint management system.- Concentrated training and experience in NCR/CAPA, QMS audits, recalls, training compliance, document control, change control, design control, process validation (IQ OQ PQ), and risk management/hazards analysis (FMECA, DFMEA, ISO 14971). - Driver in the implementation of the SAP ERP system including process validations and creation of new procedures and processes ensuring compliance of all quality system functions.- Identification and improvement of current testing protocols.
Amber Stallings Skills
Amber Stallings Education Details
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Life UniversityNutrition -
Life UniversityCoaching Psychology
Frequently Asked Questions about Amber Stallings
What company does Amber Stallings work for?
Amber Stallings works for As Qms Consulting
What is Amber Stallings's role at the current company?
Amber Stallings's current role is Regulatory Affairs Consultant.
What is Amber Stallings's email address?
Amber Stallings's email address is aj****@****ier.com
What schools did Amber Stallings attend?
Amber Stallings attended Life University, Life University.
What skills is Amber Stallings known for?
Amber Stallings has skills like Collaborative Problem Solving, Recalls, Sap Implementation, Public Speaking, Medical Nutrition Therapy, Root Cause Analysis, Gmp, Food Industry, Complaint Management, Customer Retention, Event Planning, Data Analysis.
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