Entourage, a consultancy based in Munich, Basel and Milan, is adding Dr. Nicole Affinass, Melanie Dauenhauer and Maren Krämer to its cadre of regulatory affairs experts. Dr. Nicole Affinass studied Biosciences at the University of Potsdam and Biochemistry at the Free University of Berlin. Here she later also completed her doctorate in biochemistry. As an experienced regulatory affairs manager, her core competencies include securing and maintaining the registration of currently marketed products, planning and preparing notifications of changes and submitting applications on time, coordinating and ensuring the regulatory implementation of changes, and adapting information for use and labeling texts. Melanie Dauenhauer trained as a businesswoman for office communication and organization. In addition, she completed a certificate course as a Regulatory Affairs Manager and further training in ISO 13485, post-market surveillance and internal audits for auditors in the medical device industry according to ISO 13485. As a regulatory affairs expert, she has experience in the revision and maintenance of product files, country-specific approval, in quality management as deputy QMB, in audit support and in the revision and creation of processes. Maren Krämer completed her Bachelor of Engineering with a focus on bioprocess engineering at the Frankfurt University of Applied Sciences. She then completed her Master's degree in Biomedical Engineering at the Technical University of Central Hesse. She gained professional experience in various internships, among others at a pharmaceutical company in the area of production and batch record review. Most recently, she worked for a medical device company as a Regulatory Affairs Specialist. Her competencies included international regulatory affairs, creation and maintenance of technical documentation and implementation of regulatory requirements.
Testimonials.
Dr. Nicole Affinass is excited about her new job at Entourage. "The discussions with Entourage were characterized by an open and trusting atmosphere as well as professional competence from the initial contact to the employment. Entourage is already very broadly positioned in the area of Regulatory Affairs and would like to deepen its competence even further. I am pleased that I can face these new and demanding challenges as part of Entourage." Melanie Dauenhauer is excited about her new responsibilities at Entourage. "I feel very much at home in the Entourage team. The project consulting department in particular is staffed with first-class experts who implement varied tasks for exciting customers. I'm looking forward to being a part of it." Maren Krämer is looking forward to the varied new job. "What appeals to me most is the fact that I can learn a lot in a short time. Especially in a practical way. This puts me in contact with large companies that develop and manufacture exciting devices. At the same time, I have the chance to develop further in the Entourage team." Dominik M. Aumer, Founder and Managing Partner of Entourage, is excited about the three new additions to the growing Project Consulting team. "We continue to expand our Regulatory Affairs practice and have a lot planned with our growing team. I am looking forward to having found great specialists in this field with Nicole, Melanie and Maren and to be able to staff exciting projects in the coming months and years. Welcome!"Brief Profile Dr. Nicole Affinass.
Dr. Nicole Affinass studied Biosciences at the University of Potsdam and Biochemistry at the FU Berlin. Here she later also received her doctorate in biochemistry with a focus on immunology. During her university career, she already gained experience as a research assistant and intern, for example in the biomedical field. During her subsequent training in Clinical Trial Management, Dr. Affinass gained experience in quality assessment of study-related documents, identification of quality risks and participation in audits. Most recently, she worked as a Regulatory Affairs Manager. Her responsibilities included ensuring and maintaining the registration of currently marketed products, planning and preparing change notifications, ensuring regulatory implementation of changes and timely submission of applications as well as regulatory inquiries, coordinating regulatory activities, and adapting patient information leaflets and labeling texts. Dr. Nicole Affinass supports Entourage as a Project Consultant.Short profile Melanie Dauenhauer.
Melanie Dauenhauer trained as a businesswoman for office communication and organization. She also completed a certificate course to become a Regulatory Affairs Manager and took further training in ISO 13485, post-market surveillance and internal audits for auditors in the medical device industry in accordance with ISO 13485. During her professional career in the field of Regulatory Affairs, she gained experience in the revision and maintenance of product files, country-specific approval, in quality management as deputy QMB, in accompanying audits and in the revision and creation of processes. Most recently, she worked as a Technical Documentation & Clinical Evaluation staff member. Her tasks included the creation and maintenance of technical documentation and the creation and maintenance of clinical evaluation. Melanie Dauenhauer supports Entourage as Project Consultant.Short profile Maren Krämer.
Maren Krämer first completed her Bachelor of Engineering with a focus on bioprocess engineering at the Frankfurt University of Applied Sciences. She then completed her Master's degree in Biomedical Engineering at the Technical University of Central Hesse. Ms. Krämer gained professional experience in various internships, including at a pharmaceutical company in the area of production and batch record review. Most recently, she worked for a medical device company as a Regulatory Affairs Specialist. Her responsibilities included international regulatory approval, creation and maintenance of technical documentation and implementation of regulatory requirements. Maren Krämer supports Entourage as a Project Consultant.Short Profile Entourage.
Entourage is a Life Science consulting company founded in Munich in 2013. We inspire our team to tackle new challenges and support them to go extraordinary ways to achieve the best possible. We work with market leaders in the pharmaceutical and medical device industries to develop customized solutions that create connections that build success stories. Our unique approach of project and management consulting enables us to provide unique life science solutions to our clients. We believe that our diverse and interdisciplinary team of currently over 150 employees is our key to success.Entourage is looking for life science professionals.
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