Lauren Kamer, MSPharm, RAC
Senior Director of Regulatory Affairs at Integrity Implants Inc. at Accelus- Claim this Profile
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Bio
Julie Davis-Hunter
During her time with Boehringer, Lauren proved to be an exemplary employee at all times during her career. Her work ethic was beyond reproach and she exibited many talents not seen in most holding her position. For example, due to her unique ability to teach others, Lauren was chosen to become a Certified Field Trainer for the Region. As with all things she does, Lauren excelled during this training and brought her wealth of knowledge back to Region to share with others. On many occasions, Lauren was tasked with presenting difficult clinical study data to others during our mid year meetings. Each time, the group left well prepared and with a full understanding of the data. Additionally, I have always known Lauren to be a true team player. Whatever was asked of Lauren, she was willing to assist as well as to offer her wealth of knowledge and expertise into the mix of ideas. Lauren's personality is strong yet pliable and I believe in part is why those on her team had a high level of respect for her, as I do. Finally, I know that Lauren has decided to further advance her business acumen by seeking a Masters Degree. I applaud her decision and know that this will make her that much more an asset. Lauren has much experience in the regulatory arena of the pharmaceutical industry and she will no doubt be able to further utilize this knowledge coupled with her new education. In short, I would highly recommend Lauren for employement. Her tenacity, intellligence, and work ethic are beyond that found in most. She has many contributions to offer an organization and she will certainly be missed at Boehringer Ingelheim. Julie Davis Tittenhofer
Tanya Rhodes
Lauren is a very conscientious person with great insight into whatever project she is working on. She is a very quick learner and a wonderful member of any team. I would recommend Lauren without reservation.
Julie Davis-Hunter
During her time with Boehringer, Lauren proved to be an exemplary employee at all times during her career. Her work ethic was beyond reproach and she exibited many talents not seen in most holding her position. For example, due to her unique ability to teach others, Lauren was chosen to become a Certified Field Trainer for the Region. As with all things she does, Lauren excelled during this training and brought her wealth of knowledge back to Region to share with others. On many occasions, Lauren was tasked with presenting difficult clinical study data to others during our mid year meetings. Each time, the group left well prepared and with a full understanding of the data. Additionally, I have always known Lauren to be a true team player. Whatever was asked of Lauren, she was willing to assist as well as to offer her wealth of knowledge and expertise into the mix of ideas. Lauren's personality is strong yet pliable and I believe in part is why those on her team had a high level of respect for her, as I do. Finally, I know that Lauren has decided to further advance her business acumen by seeking a Masters Degree. I applaud her decision and know that this will make her that much more an asset. Lauren has much experience in the regulatory arena of the pharmaceutical industry and she will no doubt be able to further utilize this knowledge coupled with her new education. In short, I would highly recommend Lauren for employement. Her tenacity, intellligence, and work ethic are beyond that found in most. She has many contributions to offer an organization and she will certainly be missed at Boehringer Ingelheim. Julie Davis Tittenhofer
Tanya Rhodes
Lauren is a very conscientious person with great insight into whatever project she is working on. She is a very quick learner and a wonderful member of any team. I would recommend Lauren without reservation.
Julie Davis-Hunter
During her time with Boehringer, Lauren proved to be an exemplary employee at all times during her career. Her work ethic was beyond reproach and she exibited many talents not seen in most holding her position. For example, due to her unique ability to teach others, Lauren was chosen to become a Certified Field Trainer for the Region. As with all things she does, Lauren excelled during this training and brought her wealth of knowledge back to Region to share with others. On many occasions, Lauren was tasked with presenting difficult clinical study data to others during our mid year meetings. Each time, the group left well prepared and with a full understanding of the data. Additionally, I have always known Lauren to be a true team player. Whatever was asked of Lauren, she was willing to assist as well as to offer her wealth of knowledge and expertise into the mix of ideas. Lauren's personality is strong yet pliable and I believe in part is why those on her team had a high level of respect for her, as I do. Finally, I know that Lauren has decided to further advance her business acumen by seeking a Masters Degree. I applaud her decision and know that this will make her that much more an asset. Lauren has much experience in the regulatory arena of the pharmaceutical industry and she will no doubt be able to further utilize this knowledge coupled with her new education. In short, I would highly recommend Lauren for employement. Her tenacity, intellligence, and work ethic are beyond that found in most. She has many contributions to offer an organization and she will certainly be missed at Boehringer Ingelheim. Julie Davis Tittenhofer
Tanya Rhodes
Lauren is a very conscientious person with great insight into whatever project she is working on. She is a very quick learner and a wonderful member of any team. I would recommend Lauren without reservation.
Julie Davis-Hunter
During her time with Boehringer, Lauren proved to be an exemplary employee at all times during her career. Her work ethic was beyond reproach and she exibited many talents not seen in most holding her position. For example, due to her unique ability to teach others, Lauren was chosen to become a Certified Field Trainer for the Region. As with all things she does, Lauren excelled during this training and brought her wealth of knowledge back to Region to share with others. On many occasions, Lauren was tasked with presenting difficult clinical study data to others during our mid year meetings. Each time, the group left well prepared and with a full understanding of the data. Additionally, I have always known Lauren to be a true team player. Whatever was asked of Lauren, she was willing to assist as well as to offer her wealth of knowledge and expertise into the mix of ideas. Lauren's personality is strong yet pliable and I believe in part is why those on her team had a high level of respect for her, as I do. Finally, I know that Lauren has decided to further advance her business acumen by seeking a Masters Degree. I applaud her decision and know that this will make her that much more an asset. Lauren has much experience in the regulatory arena of the pharmaceutical industry and she will no doubt be able to further utilize this knowledge coupled with her new education. In short, I would highly recommend Lauren for employement. Her tenacity, intellligence, and work ethic are beyond that found in most. She has many contributions to offer an organization and she will certainly be missed at Boehringer Ingelheim. Julie Davis Tittenhofer
Tanya Rhodes
Lauren is a very conscientious person with great insight into whatever project she is working on. She is a very quick learner and a wonderful member of any team. I would recommend Lauren without reservation.
Credentials
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RAC-DEVICES
Regulatory Affairs Certification ProgramAug, 2022- Sep, 2024 -
RAC-US
Regulatory Affairs Certification ProgramDec, 2009- Sep, 2024
Experience
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Accelus
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Senior Director of Regulatory Affairs at Integrity Implants Inc.
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Jan 2018 - Present
• Manage a team of three Regulatory Affairs Specialists with responsibility for regulatory registrations of new spinal implants and stereotaxic instrument devices in the United States, Europe, and numerous other international geographies, and for assessing the impact of device changes on global regulatory registrations • Author 510(k)s and EU Technical Documentation, including Clinical Evaluation Reports • Obtained initial EU MDD certification for novel implant device, including leading the project to conduct a retrospective clinical study in support of certification • Established systems and procedures for compliance with US and EU MDD regulatory requirements including establishment and device registration, new device development, labeling, UDI, modifications to devices, specialty device designations, and review of marketing materials • Co-led project to update QMS procedures for compliance with EU MDR requirements • Act as Deputy Management Representative for Notified Body QMS audits to support Management Representative (Director of Quality) Show less
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Zimmer Biomet
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Regulatory Affairs Manager
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Feb 2014 - Dec 2017
• Managed a team of five Regulatory Affairs Specialists with responsibility for regulatory registrations of new dental devices in the United States, Europe, Canada, Australia, and New Zealand, and for assessing the impact of device changes on global regulatory registrations • Led project team to successfully develop and implement custom order screening functionality to ensure that products are shipped only to countries for which a valid regulatory registration exists • Led project team to successfully implement FDA’s Unique Device Identification regulations, including label changes and development of a custom program for reporting regulatory/product data to FDA’s Global UDI Database (GUDID) • Established and implemented policies and procedures to ensure compliance with US custom device exemption regulations • Regulatory subject matter expert on remediation team for compliance with medical device design controls and risk analysis regulations/standards including 21 CFR 820, ISO 13485, and EN ISO 14971:2012 Show less
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Medtronic Spine & Biologics
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Medical Device
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100 - 200 Employee
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Senior Regulatory Affairs Specialist
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Dec 2010 - Feb 2014
• Responsible for contributing to product development projects by establishing global regulatory strategies, recommending appropriate verification/validation activities to support successful submissions, and authoring of submissions to support marketing of medical devices in the United States and Europe • Authoring 510(k)s for new Class II devices and device modifications • Establishing and updating Technical Files to support CE marking of MDD Class IIb, IIa, Im, and Class I devices • Reviewing marketing literature and assessing desired marketing claims to ensure appropriate substantiation activities are included as part of product development • Acting as business unit regulatory lead for assessing the impact of FDA’s proposed Unique Device Identification regulations Show less
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Merck
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Technical/Regulatory Support Specialist
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Nov 2009 - Dec 2010
Contract with Schering-Plough Consumer Healthcare in Memphis, TN • Responsible for providing technical/regulatory support for international product registrations and launches of OTC pharmaceutical products, including compiling and authoring of documents to be included in the CMC section of international dossiers Contract with Schering-Plough Consumer Healthcare in Memphis, TN • Responsible for providing technical/regulatory support for international product registrations and launches of OTC pharmaceutical products, including compiling and authoring of documents to be included in the CMC section of international dossiers
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Boehringer Ingelheim
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Germany
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Pharmaceutical Manufacturing
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700 & Above Employee
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Neurology Sales Representative/Certified Field Trainer
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May 2004 - Oct 2009
• Responsible for promoting BI products to health care professionals and dispensing drug samples in compliance with FDA regulations and PhRMA guidelines • Earned sales and credibility with customers by use of superb product knowledge skills • Achieved Certified Field Trainer designation in 10/07, and routinely conducted/assisted in product and new hire training to demonstrate “what good looks like” • Recognized as 2005 Sales Representative of the Year • Additional responsibilities have included district budget coordinator, district promotional program coordinator, district computer expert, and territory lead representative Show less
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Regulatory Analyst/Hazard Communications/Labeling Specialist
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Aug 1999 - Jul 2004
• Responsible for monitoring global chemical control, labeling, and controlled substance regulations, and developing systems to ensure compliance – including but not limited to EPA Toxic Substances Control Act (TSCA), 29 CFR Hazard Communication Regulations, EU Directives 67/548/EEC and 1999/45/EC as amended, Canada WHMIS, and Japan METI/MHLW • Executed regulatory submissions and communications with multiple agencies, including DEA, EPA, ATF, California Bureau of Narcotics Enforcement, UK Health and Safety Executive, and Health Canada; included product registrations, adverse event reporting, import/export permits • Managed global chemical hazard communication program, including coordination of MSDS and label authoring in multiple languages and regulatory formats • Led project to obtain site permit for handling/storing of controlled substances, including interpreting regulations, authoring compliance procedures, training personnel, and successfully passing audit by the US Drug Enforcement Administration (DEA) • Co-led project to implement chemical inventory database – established data conventions, specified reports to assist in maintaining chemical compliance for products, and coordinated data validation; responsible for ongoing maintenance of chemical formulation data in chemical inventory database including writing Standard Operating Procedures and training of staff Show less
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Education
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2009 - 2010
University of Florida
MS Pharmacy, Pharmaceutical Outcomes and Policy - Drug Regulatory Affairs -
1983 - 1987
University of Wisconsin-Madison
BS Education, Chemistry
Community
