Principal Regulatory Affairs Specialist
Current
Aug 2024 - Present
AeroLeads people directory · profile
Sarah Ware Email & Phone Number
Regulatory Affairs & Compliance | Medical Device | CPG | Policy and Standards Development | Product Development & Support | Process Development
at
Boston Scientific
1 work email found
@fangconsulting.com
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 100%
Current company
Role
Regulatory Affairs & Compliance | Medical Device | CPG | Policy and Standards Development | Product Development & Support | Process Development
Location
Greater Minneapolis-St. Paul Area, United States, United States
Company size
Who is Sarah Ware? Overview
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Quick answer
Sarah Ware is listed as Regulatory Affairs & Compliance | Medical Device | CPG | Policy and Standards Development | Product Development & Support | Process Development at Boston Scientific, a company with 32661 employees, based in Greater Minneapolis-St. Paul Area, United States, United States. AeroLeads shows a work email signal at fangconsulting.com and a matched LinkedIn profile for Sarah Ware.
Sarah Ware previously worked as Principal Regulatory Affairs Specialist at Boston Scientific and Principal Regulatory Affairs Consultant at Fang Consulting, Ltd. Sarah Ware holds Bachelor'S Of Science, Chemical Engineer from Iowa State University.
Company email context
Email format at Boston Scientific
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{first}@fangconsulting.com
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Profile bio
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."
Listed skills include Cross Functional Team Leadership, Quality Assurance, Operations Management, Safety Management Systems, and 33 others.
Current workplace
Sarah Ware's current company
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Boston Scientific
6 roles
Sarah Ware work experience
A career timeline built from the work history available for this profile.
Principal Regulatory Affairs Consultant
- 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.
- Review and assess changes to the design, manufacturing, labeling for impact to product approvals/submissions
- Perform detailed Global RA Assessments of Change
Mar 2018 - Aug 2024
Manager, Product Safey & Regulatory Compliance
Co-lead global team of 10 Product Safety and Regulatory Compliance specialists responsible for a $2B division while providing SME support to other divisions.
Mar 2017 - Dec 2017
Principal Product Safety Specialist
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.
Jan 2013 - Feb 2017
Manager, Material Regulatory Documentation
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.
Jul 2012 - Jan 2013
Senior Safety Engineer
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.
Jan 2010 - Dec 2011
Team & coworkers
Colleagues at Boston Scientific
Other employees you can reach at bostonscientific.com. View company contacts for 32661 employees →
JH
Julia Hornung
Colleague at Boston ScientificDüsseldorf, North Rhine-Westphalia, Germany, Germany
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IC
Isabela Carvalho
Colleague at Boston ScientificGreater Belo Horizonte, Brazil
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LH
Lauren Howard
Colleague at Boston ScientificSutton, Massachusetts, United States, United States
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PN
Padraic Noone
Colleague at Boston ScientificGalway Metropolitan Area, Ireland
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NE
Naomi Ebstein
Colleague at Boston ScientificNewton Centre, Massachusetts, United States, United States
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佐
佐々木美恵
Colleague at Boston ScientificTokyo, Tokyo, Japan, Japan
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MS
Madi Schaefer
Colleague at Boston ScientificGreater Minneapolis-St. Paul Area, United States, United States
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DN
Devin Neske, Pmp
Colleague at Boston ScientificRogers, Minnesota, United States, United States
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FV
Fran Vargas
Colleague at Boston ScientificGreater Madrid Metropolitan Area, Spain
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ME
Mikayla Essigmann
Colleague at Boston ScientificGreater Boston, United States, United States
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Julia Hornung
Colleague at Boston ScientificDüsseldorf, North Rhine-Westphalia, Germany, Germany
View →
IC
Isabela Carvalho
Colleague at Boston ScientificGreater Belo Horizonte, Brazil
View →
LH
Lauren Howard
Colleague at Boston ScientificSutton, Massachusetts, United States, United States
View →
PN
Padraic Noone
Colleague at Boston ScientificGalway Metropolitan Area, Ireland
View →
NE
Naomi Ebstein
Colleague at Boston ScientificNewton Centre, Massachusetts, United States, United States
View →
佐
佐々木美恵
Colleague at Boston ScientificTokyo, Tokyo, Japan, Japan
View →
MS
Madi Schaefer
Colleague at Boston ScientificGreater Minneapolis-St. Paul Area, United States, United States
View →
DN
Devin Neske, Pmp
Colleague at Boston ScientificRogers, Minnesota, United States, United States
View →
FV
Fran Vargas
Colleague at Boston ScientificGreater Madrid Metropolitan Area, Spain
View →
ME
Mikayla Essigmann
Colleague at Boston ScientificGreater Boston, United States, United States
View →
2 education records
Sarah Ware education
Bachelor'S Of Science, Chemical Engineer
Education record
FAQ
Frequently asked questions about Sarah Ware
Quick answers generated from the profile data available on this page.
What company does Sarah Ware work for?
Sarah Ware works for Boston Scientific.
What is Sarah Ware's role at Boston Scientific?
Sarah Ware is listed as Regulatory Affairs & Compliance | Medical Device | CPG | Policy and Standards Development | Product Development & Support | Process Development at Boston Scientific.
What is Sarah Ware's email address?
AeroLeads has found 1 work email signal at @fangconsulting.com for Sarah Ware at Boston Scientific.
Where is Sarah Ware based?
Sarah Ware is based in Greater Minneapolis-St. Paul Area, United States, United States while working with Boston Scientific.
What companies has Sarah Ware worked for?
Sarah Ware has worked for Boston Scientific, Fang Consulting, Ltd, Newell Brands, Solo Cup Company, and Bureau Veritas.
Who are Sarah Ware's colleagues at Boston Scientific?
Sarah Ware's colleagues at Boston Scientific include Julia Hornung, Isabela Carvalho, Lauren Howard, Padraic Noone, and Naomi Ebstein.
How can I contact Sarah Ware?
You can use AeroLeads to view verified contact signals for Sarah Ware at Boston Scientific, including work email, phone, and LinkedIn data when available.
What schools did Sarah Ware attend?
Sarah Ware holds Bachelor'S Of Science, Chemical Engineer from Iowa State University.
What skills is Sarah Ware known for?
Sarah Ware is listed with skills including Cross Functional Team Leadership, Quality Assurance, Operations Management, Safety Management Systems, Product Development, Strategy, Root Cause Analysis, and Technical Analysis.
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