Jacob Eric Nielsen

Jacob Eric Nielsen Email and Phone Number

CEO and Partner @ SigmaTech Nordic
Copenhagen, DK
Jacob Eric Nielsen's Location
Copenhagen, Capital Region of Denmark, Denmark, Denmark
Jacob Eric Nielsen's Contact Details

Jacob Eric Nielsen work email

Jacob Eric Nielsen personal email

About Jacob Eric Nielsen

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).

Jacob Eric Nielsen's Current Company Details
SigmaTech Nordic

Sigmatech Nordic

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CEO and Partner
Copenhagen, DK
Employees:
5
Jacob Eric Nielsen Work Experience Details
  • Sigmatech Nordic
    Ceo And Partner
    Sigmatech Nordic
    Copenhagen, Dk
  • Eit Health
    External Evaluator
    Eit Health Nov 2024 - Present
    Munich, De
    Appointed as an external evaluator (InnoStars program) as reviewer and assessor of applications for final reporting.
  • Sigmatech Nordic
    Ceo & Partner
    Sigmatech Nordic Feb 2024 - Present
    SigmaTech Nordic provides regulatory support for manufacturers of Medical Devices.
  • Mybluelabel Compliance Services
    Head Of Compliance
    Mybluelabel Compliance Services Apr 2022 - Jan 2024
    Hørsholm, Capital Region, Dk
    My 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).
  • M2Call
    Special Advisor
    M2Call Oct 2021 - Aug 2023
    My 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).
  • Boston Consulting Group
    External Advisor
    Boston Consulting Group Oct 2022 - Dec 2022
    External Advisor for design input to medical equipment related to health insurers' reimbursement schemes and medical guidelines.
  • Cortrium
    Co-Founder
    Cortrium Mar 2014 - Sep 2021
    Tåstrup, Capital Region, Dk
    I 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.
  • M2-Advice
    Founder
    M2-Advice Apr 2012 - Mar 2014
    M2-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.
  • Cxt
    Chairman Of The Board
    Cxt May 2012 - Mar 2013
    At 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.
  • M2-Fundraising
    Co-Founder & Partner
    M2-Fundraising Jan 2011 - Mar 2012
    M2-Fundraising assisted Public Authorities, Research Centres and private companies when applying for EU funding and/or Danish funding programmes.
  • C4 Foreningen & C4 Videncenter
    Eu Project Manager
    C4 Foreningen & C4 Videncenter Feb 2009 - Dec 2010
    At C4 Hillerød, I was the project manager of two projects promoting entrepreneurship and innovation under the European Regional Fund (Interreg IVA & Interreg IVC).
  • Copenhagen Plus
    Head Of Eu Office
    Copenhagen Plus Sep 2007 - Jan 2009
    Frederiksberg, Dk
  • Helsingør Municipality
    Urban Planner (Industry & Regional Development)
    Helsingør Municipality Oct 1999 - Aug 2007
  • County Of Frederiksborg (Dk Municipal Reform 2006-2007)
    Appointed Representative
    County Of Frederiksborg (Dk Municipal Reform 2006-2007) Jan 2005 - Dec 2006
    Appointed representative on behalf of Helsingør Municipality in the preparation of the structural reform in Denmark (entrepreneurial services)
  • Momentum (North Zealand)
    Member Of Board
    Momentum (North Zealand) Jan 2004 - Dec 2005
    Appointed board member on behalf of Helsingør Municipality together with representatives from 7 municipalities, County of Frederiksborg and Scion DTU.

Jacob Eric Nielsen Skills

Project Management Entrepreneurship European Union Management Consulting Start Ups Strategy Business Strategy Innovation Management Management Analysis Public/private Partnerships Organizational Development Research Establishment English Public Relations International Relations Change Management Strategic Planning Market Research Project Coordination Economics Intercultural Communication Leadership Development Event Management Politics Climate Change Public Speaking Social Media Funding Strategic Communications Policy Analysis Program Management International Project Management R&d Business Planning Public Policy Negotiation Marketing Communications Product Development Sustainable Development Team Leadership Leadership Project Planning Business Development Marketing Strategy Coaching New Business Development Eu Project Management Public Private Partnership

Jacob Eric Nielsen Education Details

  • University Of Copenhagen
    University Of Copenhagen
    Political 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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