Jacob Eric Nielsen work email
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Jacob Eric Nielsen personal email
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From C-level and project management positions, I’m motivated to acquire funding, CE-certification and commercialization of medical products and services.Here are some highlights:- Cortrium (2014-2021): As Co-founder and CEO I initiated the funding process and raised 4M€ to develop an ECG monitor device for arrhythmia detection designed with reference to Diagnosis-Related Group (DRG) for health insurers reimbursement. As CEO, I established a co-marketing collaboration with Pfizer Germany. I mobilized a team of engineers as project manager of the technical documentation to acquire certification (ISO13485 & CE-class IIa)- M2Call (2021-2023): As COO and Special Advisor, I managed to establish a strategic partnership with Siemens Healthineers and Rigshospitalet (DK). Also, I was a co-inventor on a patent for ICU patient monitoring. I was the project lead on implementing MDR requirements for certification (CE-mark)- MyBlueLabel (2022-2023): I have provided regulatory support and on-boarding on eQMS to 60+ companies (MDR, IVDR and/or FDA), and acted as external project lead on four certification projects (MDR & IVDR).Outside my health industry career, I have also been entrusted with management positions on several research-based business cases, i.e., building excellence centres with Danish Technical University (DTU) and Aarhus University, and leading on sales processes for green economy and eMobility solutions (i.e. Sensitivus Gauge).
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Ceo And PartnerSigmatech NordicCopenhagen, Dk -
External EvaluatorEit Health Nov 2024 - PresentMunich, DeAppointed as an external evaluator (InnoStars program) as reviewer and assessor of applications for final reporting. -
Ceo & PartnerSigmatech Nordic Feb 2024 - PresentSigmaTech Nordic provides regulatory support for manufacturers of Medical Devices. -
Head Of ComplianceMybluelabel Compliance Services Apr 2022 - Jan 2024Hørsholm, Capital Region, DkMy job:- NewBizz: Sales of eQMS platform and regulatory services.- eQMS: Providing input to the design of regulatory Tech software solutions.- Consultancy services: Providing regulatory support to customers such as project management, technical writing and business strategies for product design that matches health insurers' reimbursement schemes. The assignments cover various diagnostic and therapeutic devices, i.e., within cardiology, neurology, oncology, haematology, urology, pathology, psychiatry, endocrinology, paediatrics, internal medicine, surgery tools, geriatrics, emergency medicine and critical care.My achievements:- Regulatory support and onboarding of 60+ new customers to the MyBlueLabel platform (2022-2023).- Project management on four customer certification projects (MDR, IVDR). -
Special AdvisorM2Call Oct 2021 - Aug 2023My job was to drive the path to take out the patent of joint development with health research institutions. Also, to initiate the sales channel via Siemens Healthineers and the compliance journey for the CE-mark with medical regulations.My Achievements:1) Patent application filed (Camera-based seizure detection - Epilepsy).2) Quality Management System setup according to ISO 134853) Technical documentation setup according to MDR (EU) 2017/7454) Project lead: Setup design and development plan of Migo product, handling of Notified Body contract, and setup of clinical testing of a prototype with ethical committee approval.5) License agreement: Handling of acquiring a license to technology from the Capital Region of Denmark (Rigshospitalet). -
External AdvisorBoston Consulting Group Oct 2022 - Dec 2022External Advisor for design input to medical equipment related to health insurers' reimbursement schemes and medical guidelines.
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Co-FounderCortrium Mar 2014 - Sep 2021Tåstrup, Capital Region, DkI started Cortrium with a team of engineers and medical doctors as CEO. From Autumn 2015, I acted as CEO/COO and managed the company operations via various seed-funding rounds with Canadian, German and Danish investors.In Autumn 2017 I was reappointed as CEO with three objectives; 1) to set up a sales channel with Pfizer, 2) to acquire the medical CE mark for the company's product and 3) to prepare the company for an A-round investment.Achievements:The CE-mark was achieved in March 2018, and in August 2018 the A-round was obtained, and mostimportantly; Sales targets with Pfizer of 2.000 devices were met (2019-2021), and besides the EU, theproduct was registered in the UK, Australia and India.In 2021, I left the daily operations at Cortrium. When I left, the company had launched products and services in 15+ markets with 600+ customers. Also, I look back on a Cortrium team that has grown from two persons in 2014 to 25+ employees in 2021.After Cortrium, I have been focusing on the commercialization of medical devices via certification and setup of sales channels for various HealthTech providers. -
FounderM2-Advice Apr 2012 - Mar 2014M2-advice is a consultancy. In M2-advice, I have assisted public bodies, universities, research centres and private companies when forming public-private partnerships and with application writing for i.e., EU funding.
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Chairman Of The BoardCxt May 2012 - Mar 2013At CXT (Copenhagen X-prize Team) we opened the labs of the former NOKIA premises in Copenhagen. Engineers, Medical Doctors, Industrial designers and business developers were gathered to health events and weekly demo days of accomplished achievements in health data monitoring and data visualization.
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Co-Founder & PartnerM2-Fundraising Jan 2011 - Mar 2012M2-Fundraising assisted Public Authorities, Research Centres and private companies when applying for EU funding and/or Danish funding programmes.
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Eu Project ManagerC4 Foreningen & C4 Videncenter Feb 2009 - Dec 2010At C4 Hillerød, I was the project manager of two projects promoting entrepreneurship and innovation under the European Regional Fund (Interreg IVA & Interreg IVC). -
Head Of Eu OfficeCopenhagen Plus Sep 2007 - Jan 2009Frederiksberg, Dk -
Urban Planner (Industry & Regional Development)Helsingør Municipality Oct 1999 - Aug 2007
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Appointed RepresentativeCounty Of Frederiksborg (Dk Municipal Reform 2006-2007) Jan 2005 - Dec 2006Appointed representative on behalf of Helsingør Municipality in the preparation of the structural reform in Denmark (entrepreneurial services)
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Member Of BoardMomentum (North Zealand) Jan 2004 - Dec 2005Appointed board member on behalf of Helsingør Municipality together with representatives from 7 municipalities, County of Frederiksborg and Scion DTU.
Jacob Eric Nielsen Skills
Jacob Eric Nielsen Education Details
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University Of CopenhagenPolitical Science And Cinematography
Frequently Asked Questions about Jacob Eric Nielsen
What company does Jacob Eric Nielsen work for?
Jacob Eric Nielsen works for Sigmatech Nordic
What is Jacob Eric Nielsen's role at the current company?
Jacob Eric Nielsen's current role is CEO and Partner.
What is Jacob Eric Nielsen's email address?
Jacob Eric Nielsen's email address is jn****@****sing.dk
What schools did Jacob Eric Nielsen attend?
Jacob Eric Nielsen attended University Of Copenhagen.
What are some of Jacob Eric Nielsen's interests?
Jacob Eric Nielsen has interest in Education, Health.
What skills is Jacob Eric Nielsen known for?
Jacob Eric Nielsen has skills like Project Management, Entrepreneurship, European Union, Management Consulting, Start Ups, Strategy, Business Strategy, Innovation Management, Management, Analysis, Public/private Partnerships, Organizational Development.
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