Sandy Leclair, Ms Ra work email
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Sandy Leclair, Ms Ra personal email
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* M.S. Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University in 2015. * 18 years Global Class I, II, and III medical device and In Vitro Diagnostics Regulatory Affairs experience including design history files, all phases of product lifecycle from device design thru market release, post market surveillance and post market activities. * Active interaction with the FDA, the European Union, Japan, Australia, China, Canada, Mexico, and many other countries around the globe for efficient product registrations.* Thorough understanding of Medical Device Reporting, determining reportable events, initial mandatory reporting deadlines, and supplemental reports. * Comprehensive understanding of drug submissions; pre-NDA, NDA, and post-NDA process, reporting requirements including Drug Master Files. As well as Generic Drug submissions, the ANDA process, bioequivalence and therapeutic equivalence.* Responsible for supporting all aspects of the Quality Assurance program within the Quality Management System, including internal/external quality issue resolution, supplier quality issues, CAPA, and customer complaints in order to drive process improvements. * Project management including projects for global market expansion, Human Factors Study in support of 510K submission and Tech File remediation for EU MDR compliance.* Independently authored and obtained clearance for 6 510(k) submissions for Class 2 medical devices and esubmissions, as well as facilitate pre-submission meetings. * US, EU, and ROW packaging and labeling. * Effectively interpret and communicate US, EU and OUS regulations to product design and development teams. * Education and experience in US Code of Federal Regulations, EU Medical Device Regulation 2017, Quality Systems, recognized standards including EN ISO 13485, EN ISO 14155, EN ISO 14971, IEC 60601, IEC 62304, IEC 62366, EN ISO 10993, EN ISO 11607.
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Ra And Qa ConsultantMed-SherpaMohawk, Ny, Us
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Director Of Regulatory AffairsSs White Dental Aug 2023 - PresentLakewood, Nj, UsOversees all regulatory matters and executes strategy to ensure organizational compliance with global regulations. Develop processes and systems to ensure necessary licenses and filings, certifications and permits are processed and monitored. Establish monitoring policies and procedures to ensure compliance with existing regulations. Anticipate new or changing regulations an coordinates with internal stakeholders to develop strategies to address changes in product, operation, or testing requirements. Investigate and report issues of non-compliance. Manage department sub-function and create functional strategies, specific objectives and budgets, policies, procedures to support the functional infrastructure. Lead key negotiations with global regulatory bodies. Coach/consult and manage junior regulatory associates and outside consultants. Monitor and maintain valid legal status with all government sanctions. Gain clearances for 510(k) and PMA clearances. Merger and acquisition regulatory assessment, strategy, management and implementation. Domestic and international regulatory compliance strategy development. Manage regulatory team to ensure global RA responsibilities are met. UDI and BUDI compliance coordination and maintenance. Post Market Surveillance Strategy. QMS support, strategy and Project management. Laison with appropriate regulatory agencies. Perform duties as Person Responsible for Regulatory Compliance (PRRC). Results oriented with a goal of achieving product registration in a timely fashion. -
Ra/Qa ConsultantMed-Sherpa May 2021 - Present• Updating creating company procedures to current requirements• Providing regulatory and quality guidance to clients• Collaboration with client cross functional teams.
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Sr. Regulatory Affairs SpecialistInogen Mar 2022 - Jun 2023Goleta, California, Us• Providing regulatory guidance to cross-functional teams regarding US, EU, UKCA, MDSAP and ROW requirements regarding functional testing, labeling, biocompatibility testing, clinical evaluation, risk management and components as accessories for stationary and portable oxygen concentrators.• Authoring POC Class II 510k submissions. • Creating regulatory plans and assessments for new products. -
Medical Device And Diagnostic ResearchIcon Plc Jan 2020 - Mar 2022Dublin, Ie• Author Class B and C In Vitro Diagnostics Clinical Evaluation Reports (CPR), Scientific Validity Reports (SVR), GSPR’s and STED Documents.• Participate in regulatory and clinical trial project teams.• Plan and track designated project activities.• Initiate product research and regulatory intelligence in support of regulatory activities and communicate regulatory requirements.• Contribute to core regulatory submissions. -
Regulatory Affairs ConsultantLeclair Ra Feb 2020 - Mar 2020• Support response to Notified Body Audit findings.• Author Clinical Evaluation SOP.• Update Clinical Evaluation Plan and Report..
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Regulatory Affairs ConsultantCarlton National Resources Dec 2019 - Mar 2020Wakefield, Ma, Us• Initiate product research and regulatory intelligence to provide recommendation of appropriate regulatory pathway in support of regulatory submission.• Author distributor contracts and SOP’s in support of audit response.• Plan and track international product registrations.• Analysis of current product registrations and communicate gaps to key stakeholders.• Participate in regulatory project teams. -
Global Regulatory Affairs Project ManagerIntepros Consulting May 2018 - Dec 2019Waltham, Ma, Plymouth Meeting, Pa, , UsManage global medical device and drug product registrations, interactions with in-country regulatory affairs personnel, distributors, and Health Authorities. Provide guidance to regional registration personnel as needed, manage conflict and registration issues. Provide regulatory strategies, priorities, resource recommendations for market expansion to key stakeholders. -
Sr. Technical WriterValidant Feb 2018 - May 2018San Francisco, Ca, UsEU MDR Migration -
Regulatory Affairs Project LeadIntepros Consulting Jul 2017 - Dec 2017Waltham, Ma, Plymouth Meeting, Pa, , Us• Oversight of regulatory registrations for dental implants, data collection, verification and block release• Lead team members in achieving desired data verification.• Align with regional and in-country RA teams on data collection and verification• Develop and maintain GTS training and procedures• Conduct training for in- country and Business Unit RA teams on GTS as needed• Maintain and ensure data integrity and completeness in GTS• Develop and conduct periodic audit plans to ensure quality data• Coordinate with regional and in-country RA teams to identify training needs• Manage GTS records keeping and organization• Identify training needs, and optimize business process
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Regulatory Affairs ConsultantBlack Diamond Networks Jun 2017 - Oct 2017Andover, Massachusetts, Us* Quality System development per the new EU MDR Medical Device Regulation, 21 CFR 820 FDA Quality System Requirements, and ISO 13485: 2016.* Manage and develop General Safety and Performance Requirements checklist for products being marketed in the EU in compliance with the new MDR (medical device regulation). * Provide guidance on requirements and determine acceptable conformity methods for CE marking to bring new class III devices to market. -
Staff Regulatory Affairs SpecialistBd Oct 2016 - May 2017Franklin Lakes, New Jersey, UsResponsible for Regulatory Affairs activities for the Self-Administration Injection Systems (SAIS) within the Medical-Pharmaceutical Systems•Participated in implementation of EU Medical Device Regulation (MDR) trainings in preparation for the new MDR requirements.•Develop and execute worldwide regulatory strategies for complex combination products and medical devices•Prioritize, develop and advance regulatory partnerships with pharmaceutical customers •Participate in interactions with Health Authorities such as FDA, Health Canada, EU and other international authorities•Responsible for overseeing the generation and maintenance of product registration files such as Technical Files, Device Master Files, and international registration dossiers.•Interaction with cross-functional product develop teams and provide direction and guidance on regulatory related issues. -
Sr. Regulatory Affairs SpecialistEg Life Sciences Apr 2016 - Oct 2016Reading, Massachusetts, Us• Lead Quality System Continuous improvement, and corrective and preventive action (CAPA) and non-conforming (NC) system processes.• Regulatory representative on cross-functional PMA teams for defibrillation devices to ensure evidence effectively demonstrates safety and efficacy of the devices for Premarket approval.• Responsible for providing regulatory information for UDI submissions.• Prepare the regulatory documentation for relocation to sister facility.• Created Regulatory US and International registration database for reference by sister facility.• Conduct gap analysis of Technical Files, labels and labeling, and design creation and changes.• Report to management gaps in regulatory requirements needed to ensure U.S. and ROW compliance.• Work with cross functional CAPA teams including subject matter experts to perform root cause analysis using root cause mythology and tools such as Ishikawa diagrams, Is Is-Not, Timeline, or 5 Whys analysis.• Prepare plans to correct or prevent recurrence of nonconformities per FDA QSR 21 CFR 820.100.• Present corrective and preventive action plans to quality management for approval.• Ensure timely completion and documentation of each phase conducted within the corrective or preventive action plan.• Prepare regulatory strategies and due diligence for manufacturing site changes. -
Sr. Complaint SpecialistEg Life Sciences Oct 2015 - Apr 2016Reading, Massachusetts, UsComplaint management for wireless diabetes management system including the receipt, documentation, processing FDA Medical Device Reports (MDR) and EU Medical Device Vigiliance reports (MDV), investigation, resolution, and closure of all product quality complaints and patient-related field events in compliance with regulatory requirements (21CFR Parts 210, 211, 820).
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Regulatory Affairs SpecialistConmed Corporation Aug 2005 - Oct 2015Largo (Tampa Bay), Fl, Us
Sandy Leclair, Ms Ra Skills
Sandy Leclair, Ms Ra Education Details
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Northeastern UniversityBiologics And Medical Devices -
Raps Online UniversityGlobal Regulatory Affairs
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Utica UniversityBusiness Administration
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High School
Frequently Asked Questions about Sandy Leclair, Ms Ra
What company does Sandy Leclair, Ms Ra work for?
Sandy Leclair, Ms Ra works for Med-Sherpa
What is Sandy Leclair, Ms Ra's role at the current company?
Sandy Leclair, Ms Ra's current role is RA and QA Consultant.
What is Sandy Leclair, Ms Ra's email address?
Sandy Leclair, Ms Ra's email address is sa****@****plc.com
What schools did Sandy Leclair, Ms Ra attend?
Sandy Leclair, Ms Ra attended Northeastern University, Raps Online University, Utica University, High School.
What skills is Sandy Leclair, Ms Ra known for?
Sandy Leclair, Ms Ra has skills like Us Regulations, Eu Regulations, 510 K, Complaint Management, Post Market Surveillance, Mdrs, Fda, Iso 13485, Regulatory Affairs, Medical Devices, Quality System, Iso 14971.
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