Sarah Ware

Sarah Ware Email and Phone Number

Regulatory Affairs & Compliance | Medical Device | CPG | Policy and Standards Development | Product Development & Support | Process Development @ Boston Scientific
marlborough, massachusetts, united states
Sarah Ware's Location
Greater Minneapolis-St. Paul Area, United States
Sarah Ware's Contact Details
About Sarah Ware

Sarah Ware is a Regulatory Affairs & Compliance | Medical Device | CPG | Policy and Standards Development | Product Development & Support | Process Development at Boston Scientific. She possess expertise in cross functional team leadership, quality assurance, operations management, safety management systems, product development and 32 more skills. She is proficient in English. Colleagues describe her as "I have worked with Sarah for about two years and in this short duration she has impressed me with her dedication, knowledge, resourcefulness, and hard work. She is an enthusiastic, ethical, diligent, and organized professional. She has a can-do attitude and sets high expectations for herself and others. Sarah always demonstrated a strong ability to work well with both internal and external clients. She has consistently gained clients’ appreciation for her diligence and professionalism. Sarah would be an asset to any organization." and "I'm happy to be able to write a recommendation of Sarah's work. Sarah came to SMAP with a confidence that immediately showed her experience and knowledge while adding a positive energy to the group. She was always willing to train or explain concepts and share her knowledge, working to strengthen the department and company - not just herself. Sarah Evans was a positive mentor who was a pleasure to work with."

Sarah Ware's Current Company Details
Boston Scientific

Boston Scientific

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Regulatory Affairs & Compliance | Medical Device | CPG | Policy and Standards Development | Product Development & Support | Process Development
marlborough, massachusetts, united states
Employees:
32661
Sarah Ware Work Experience Details
  • Boston Scientific
    Principal Regulatory Affairs Specialist
    Boston Scientific Aug 2024 - Present
  • Fang Consulting, Ltd
    Principal Regulatory Affairs Consultant
    Fang Consulting, Ltd Mar 2018 - Aug 2024
    Greater Minneapolis-St. Paul Area
    • Manage a team of Regulatory and Quality Consultants on key projects for major medical companies• Provide internal and external training on the application of global chemical regulations to specific products and strategies to manage compliance.• Perform deep dive gap assessments to Regulation (EU) 2017/745 (MDR) for Class IIa, IIb, and III files and provide guidance on bridging deficiencies • Device Submissions:- Remediate files for EU MDD- Develop STED format technical files for EU and International Registrations- Review CERs and suggest revisions to bring state of the art (per MEDDEV 2.7/1 Rev. 4)- Create Letters to File, US Class III device changes- Prepare STED/DD and GSPR MDR submissions• Review and assess changes to the design, manufacturing, labeling for impact to product approvals/submissions• Perform detailed Global RA Assessments of Change• Review raw materials and supply chain processes for high risk chemical substances for MDR, and Prop65 compliance
  • Newell Brands
    Manager, Product Safey & Regulatory Compliance
    Newell Brands Mar 2017 - Dec 2017
    Downers Grove, Illinois
    Co-lead global team of 10 Product Safety and Regulatory Compliance specialists responsible for a $2B division while providing SME support to other divisions.
  • Newell Brands
    Principal Product Safety Specialist
    Newell Brands Jan 2013 - Feb 2017
    Downers Grove, Illinois
    Provided SME expertise in areas of regulatory compliance, product safety, risk management, conformity assessment, process development and trend analysis across an extremely diverse portfolio including medical device, toys, food contact, writing instruments, and chemicals.
  • Solo Cup Company
    Manager, Material Regulatory Documentation
    Solo Cup Company Jul 2012 - Jan 2013
    Developed and implemented long term strategy to align Solo/Dart integration after merger. Validated FDA compliance for all materials and products, and ensured due diligence requirements were met.
  • Bureau Veritas
    Senior Safety Engineer
    Bureau Veritas Jan 2010 - Dec 2011
    Downers Grove, Il
    Provided Strategic and Technical Consulting in the areas of regulatory compliance and chemical management activities in the areas of health, safety, environment and consumer perceived safety.

Sarah Ware Skills

Cross Functional Team Leadership Quality Assurance Operations Management Safety Management Systems Product Development Strategy Root Cause Analysis Technical Analysis Analytical Skills Risk Management Management Process Engineering Product Safety Quality System Chemical Safety Regulatory Knowledge Standards Development Data Analysis Strategic Consulting Product Stewardship Regulatory Analysis Quality Management Regulatory Strategy Incident Analysis Safety Management Analytical Abilities Continuous Improvement Regulatory Continuous Process Improvement Policy Development Regulatory Impact Analysis Restricted Substances Regulatory Affairs Medical Devices U.s. Food And Drug Administration Project Management Research And Development

Sarah Ware Education Details

Frequently Asked Questions about Sarah Ware

What company does Sarah Ware work for?

Sarah Ware works for Boston Scientific

What is Sarah Ware's role at the current company?

Sarah Ware's current role is Regulatory Affairs & Compliance | Medical Device | CPG | Policy and Standards Development | Product Development & Support | Process Development.

What is Sarah Ware's email address?

Sarah Ware's email address is sa****@****cup.com

What schools did Sarah Ware attend?

Sarah Ware attended Iowa State University, University Of Minnesota.

What skills is Sarah Ware known for?

Sarah Ware has skills like Cross Functional Team Leadership, Quality Assurance, Operations Management, Safety Management Systems, Product Development, Strategy, Root Cause Analysis, Technical Analysis, Analytical Skills, Risk Management, Management, Process Engineering.

Who are Sarah Ware's colleagues?

Sarah Ware's colleagues are Rachel Rumbaugh, Chad Prevost, Colin Campbell, Steve Zhang, Peter Bokor, Naveen Velagapudi, Jeanette Persson.

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