Aneta Modzelewska Ph.D., RAC
Director, Regulatory Sciences at Senseonics, Incorporated- Claim this Profile
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English Native or bilingual proficiency
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Polish Native or bilingual proficiency
Topline Score
Bio
Credentials
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Regulatory Affairs Certification (RAC) - Devices
Regulatory Affairs Professionals Society (RAPS)May, 2022- Nov, 2024 -
RAPS Medical Device Certification Program
Regulatory Affairs Professionals Society (RAPS)Apr, 2021- Nov, 2024 -
Decision-Making in High-Stress Situations
LinkedInSep, 2020- Nov, 2024 -
Executive Presence on Video Conference Calls
LinkedInSep, 2020- Nov, 2024 -
RAPS Member
Regulatory Affairs Certification ProgramNov, 2015- Nov, 2024
Experience
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Senseonics, Incorporated
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United States
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Medical Equipment Manufacturing
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100 - 200 Employee
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Director, Regulatory Sciences
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Dec 2019 - Present
Reporting to Chief Operating Officer• Lead and execute regulatory submissions in U.S. and EU (IDE, PMA, EU MDR Technical Documentation).• Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies.• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.• Provide critical review of all documentation supporting regulatory applications. • Review, evaluate, and approve marketing materials to ensure compliance with regulations, internal and external guidelines.• Collaborate with cross-functional teams to resolve concerns and questions from regulatory authorities.• Monitor applicable current and new regulatory requirements.• Review and update regulatory processes and documentation practices to ensure company is in compliance and audit ready. Show less
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Manager, Regulatory Sciences
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Jul 2018 - Dec 2019
Reporting to Chief Operating Officer • Manage and execute regulatory submissions in U.S. and EU (IDE, PMA, Design Dossier).• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.• Interact with cross-functional teams to resolve concerns and questions from regulatory authorities.• Review technical and clinical documentation to ensure accuracy and appropriateness for regulatory filings.• Review product labeling/advertising to ensure compliance with federal regulations.• Provide support to marketing, R&D and manufacturing teams in regulatory assessment of proposed product changes.• Responsible for ISO 10993 biocompatibility evaluation and testing of new and modified products/accessories for Senseonics CGM System. Show less
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Principal, Regulatory Sciences
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Nov 2015 - Jul 2018
Reporting to Chief Operating Officer • Lead for regulatory submissions in U.S. and EU (IDE, PMA, Design Dossier)• Core team member preparing for and attending FDA Advisory Committee Meeting • Interact with cross-functional teams to resolve concerns and questions from regulatory agencies.• Review technical and clinical documentation to ensure accuracy and appropriateness for regulatory filings.• Provide support to marketing, R&D and manufacturing teams in regulatory assessment of proposed product changes.• Responsible for ISO 10993 biocompatibility testing of new and modified products/accessories for Senseonics CGM System. Show less
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Principal Scientist
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Oct 2011 - Nov 2015
• Lead and managed multiple projects in support of R&D and production efforts.• Development and implementation of a continuous glucose monitoring system.• Directed and managed biocompatible coatings and membranes program. • Coordinated projects involving multiple vendors to implement new chemistries for CGM device. • Responsible for performing root cause failure analysis for developed product and various production processes.• Managed and designed in vivo studies in small mammals of novel chemistries and alternative glucose sensor configurations.• Lead investigation of hydrogel morphology; inter and intra lot variability.• Project lead for ISO 10993 testing for fully implantable continuous glucose monitoring system. Show less
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Senseonics, Incorporated
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United States
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Medical Equipment Manufacturing
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100 - 200 Employee
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Scientist II
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Jul 2010 - Oct 2011
• Designed and managed in vivo studies of novel chemistries and alternative glucose sensor configurations.• Optimized product manufacturing processes.• Prepared documents (CPF, WI, MS, RS) to support product transfer to production. • Pursued catalytic oxidants syntheses and evaluation in order to improve in vivo stability of glucose sensing hydrogels.• Continued development of bio-absorbable polymers for glucose sensing.
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Scientist I
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Jul 2006 - Jul 2010
• Designed and synthesized variety of fluorescent molecules with improved resistance to oxidation.• Synthesized lead molecule with high purity to meet FDA standards for pilot studies. • Synthesized cyclen analogs and SOD mimetics in order to evaluate and improve in vivo stability of indicator molecule embedded in hydrogel matrix.• Developed and extensively tested bioabsorbable polymers used for in vitro and in vivo studies.• Developed and optimized extrusion process for bioabsorbable polymers. Show less
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The Johns Hopkins University School of Medicine
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United States
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Hospitals and Health Care
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700 & Above Employee
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Postdoctoral Fellow in Oncology Department
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2003 - 2006
• Designed and synthesized novel chalcones containing boronic acid moiety to be potent and specific MDM2 inhibitors. • Tested the potency of these molecules against breast cancer and colon cancer cell lines. • Performed SAR studies on the aforementioned inhibitors. • Designed and developed second generation of complex molecules based on docking studies with MDM2 oncoprotein. • Optimized and synthesized the lead molecules for in vitro and in vivo testing against breast cancer cell lines. Show less
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Education
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1998 - 2003
Uniwersytet im. Adama Mickiewicza w Poznaniu
Ph.D., Organic Chemistry -
1993 - 1998
Uniwersytet im. Adama Mickiewicza w Poznaniu
M.Sc., Organic Chemistry -
2001 -
University of Florida
Fluoroorganic Chemistry
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