Joy Gutermuth
Consultant at RQM+- Claim this Profile
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English Native or bilingual proficiency
Topline Score
Bio
Credentials
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RAPS Member
Regulatory Affairs Certification ProgramMar, 2021- Sep, 2024 -
Crematory Operator
Cremation Association of North AmericaSep, 2014- Sep, 2024 -
Licensed Embalmer
Ohio Board of Embalmers and Funeral Directors -
Licensed Funeral Director
Ohio Board of Embalmers and Funeral Directors
Experience
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RQM+
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United States
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Business Consulting and Services
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300 - 400 Employee
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Consultant
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Mar 2021 - Present
RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators… Show more RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies. • Regulatory strategy and pathway analysis • Predicate search and recommendation • Pre-submission composition and support • Regulatory gap assessment and remediation guidance • US FDA Pre-market authorization submissions of Class I, II, and III medical devices • Traditional, Abbreviated, and Special 510(k) submission composition and support • PMA supplements • Technical File gap assessments and remediation guidance Show less RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators… Show more RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies. • Regulatory strategy and pathway analysis • Predicate search and recommendation • Pre-submission composition and support • Regulatory gap assessment and remediation guidance • US FDA Pre-market authorization submissions of Class I, II, and III medical devices • Traditional, Abbreviated, and Special 510(k) submission composition and support • PMA supplements • Technical File gap assessments and remediation guidance Show less
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Applied Medical Technology, Inc. (AMT)
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United States
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Medical Equipment Manufacturing
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100 - 200 Employee
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Regulatory Affairs Specialist II
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Feb 2018 - Mar 2021
• Regulatory strategy and submission planning. • 510(k) premarket notifications for new medical devices and respond to time-sensitive requests from the FDA in order to obtain device clearance. • FDA clearance on 4 Traditional 510(k) submissions of class II gastroenterology/urology devices (average 91 total days to clear). • 513(g) requests. • Knowledgeable in product codes EXD, KNT, KGC, PIF; 21 CFR §876.5980. • Predicate search and regulatory pathway analysis for new… Show more • Regulatory strategy and submission planning. • 510(k) premarket notifications for new medical devices and respond to time-sensitive requests from the FDA in order to obtain device clearance. • FDA clearance on 4 Traditional 510(k) submissions of class II gastroenterology/urology devices (average 91 total days to clear). • 513(g) requests. • Knowledgeable in product codes EXD, KNT, KGC, PIF; 21 CFR §876.5980. • Predicate search and regulatory pathway analysis for new products. • Internal quality systems auditing. • Strong understanding of ISO 10993 series, ISO 80369 series.
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Quality Assurance Technician
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Aug 2017 - Feb 2018
• Perform receiving inspection with difficult measurements • Analyze and report on product complaints from customers • Use tensile machine to perform weekly destructive testing of product • Assist QA/Regulatory Supervisor with projects • Assist in the distribution and filing of QA documents
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Alexander Mann Solutions
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United Kingdom
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Staffing and Recruiting
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100 - 200 Employee
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Recruitment Coordinator for Bank of America
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Dec 2016 - Aug 2017
• Coordinate all aspects of high-volume post-offer acceptance onboarding process of new hires across unique lines of business for Bank of America. • Meticulously synthesize offer letters and store returned documentation according to storage and retention guidelines. • Ensure adherence to strict regulatory and compliance guidelines • Coordinate all aspects of high-volume post-offer acceptance onboarding process of new hires across unique lines of business for Bank of America. • Meticulously synthesize offer letters and store returned documentation according to storage and retention guidelines. • Ensure adherence to strict regulatory and compliance guidelines
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Malloy Memorial
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United States
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Consumer Services
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Licensed Funeral Director / Crematory Operator / Office Administrator
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Aug 2016 - Nov 2016
• Receive all incoming phone calls to the funeral home’s main line; answer inquires, take precise and detailed messages, and transfer calls appropriately. • Critically think in order to prioritize workload among Medical Examiner duties, crematory operations, at-need and pre-need funeral arrangements, and regular business functions. • Schedule and meet with clients on both an at-need and pre-need basis to contract and sell funeral goods and services in accordance with state and federal… Show more • Receive all incoming phone calls to the funeral home’s main line; answer inquires, take precise and detailed messages, and transfer calls appropriately. • Critically think in order to prioritize workload among Medical Examiner duties, crematory operations, at-need and pre-need funeral arrangements, and regular business functions. • Schedule and meet with clients on both an at-need and pre-need basis to contract and sell funeral goods and services in accordance with state and federal laws while providing excellent customer service. • Delegate, monitor, and meticulously oversee the progress of projects, client requests, and assignments while ensuring funeral services are provided according to strict timelines. Show less • Receive all incoming phone calls to the funeral home’s main line; answer inquires, take precise and detailed messages, and transfer calls appropriately. • Critically think in order to prioritize workload among Medical Examiner duties, crematory operations, at-need and pre-need funeral arrangements, and regular business functions. • Schedule and meet with clients on both an at-need and pre-need basis to contract and sell funeral goods and services in accordance with state and federal… Show more • Receive all incoming phone calls to the funeral home’s main line; answer inquires, take precise and detailed messages, and transfer calls appropriately. • Critically think in order to prioritize workload among Medical Examiner duties, crematory operations, at-need and pre-need funeral arrangements, and regular business functions. • Schedule and meet with clients on both an at-need and pre-need basis to contract and sell funeral goods and services in accordance with state and federal laws while providing excellent customer service. • Delegate, monitor, and meticulously oversee the progress of projects, client requests, and assignments while ensuring funeral services are provided according to strict timelines. Show less
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Dispatcher
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Aug 2016 - Nov 2016
• Contracted by the Cuyahoga County Medical Examiner’s office to answer phone calls detailing specifics of crime scene mortality and other suspicious death cases in Cuyahoga County in order to obtain necessary decedent and scene information from the investigation team. • Dispatch and maintain communication with appropriate removal personnel on a strict time constraint from the scene location until remains are properly delivered to and documented by the medical examiner’s office. • Contracted by the Cuyahoga County Medical Examiner’s office to answer phone calls detailing specifics of crime scene mortality and other suspicious death cases in Cuyahoga County in order to obtain necessary decedent and scene information from the investigation team. • Dispatch and maintain communication with appropriate removal personnel on a strict time constraint from the scene location until remains are properly delivered to and documented by the medical examiner’s office.
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Ripepi Funeral Home Inc
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United States
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Consumer Services
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1 - 100 Employee
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Funeral Director / Administrator
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Mar 2016 - Jul 2016
• Represented the first point of contact for families in first call conversations and regularly answered critical inquiries both in person and on the phone. • Scheduled meetings with families and clients for funeral arrangements; quoted funeral prices based on selected services and wrote contracts. • Greeted and provided hospitality for families and visitors for appointments and funeral services.
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Apprentice / Administrative Assistant
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Feb 2015 - Feb 2016
• Drafted and published obituaries along with service information to an interactive company website and newspapers. • Ensured compliance with state and federal laws governing funeral services and final disposition.
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Education
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2013 - 2014
Pittsburgh Institute of Mortuary Science Inc
Associate's degree, Funeral Service Arts and Sciences -
2010 - 2014
Thiel College
Bachelor of Arts (BA), Business Administration
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