About

Cormedics Medizintechnik GmbH is a service orientated consulting company for medical devices.

Our mission is to assist our customers in introducing innovative medical technologies to the European market and provide customized product commercialization and distribution models for new product development concepts. Our focus is on medical devices especially for the fields of Cardiology, Cardiac Surgery, Vascular Surgery and Interventional Radiology

Cormedics is committed to the professional and competent representation of our partners, as well as attaining the trust of the physicians and hospitals we call on.

It is this philosophy and dedication to service that has been the paradigm for Cormedics since its founding in 1987. As a distributor Cormedics has successfully represented numerous companies in bringing important, cutting-edge technologies to market, such as SciMed Lifesystems, Webster or World Medical. Since then our General Manager Michael Braun and his experienced team develop customized strategies and support for innovative companies, which intend to successfully launch their products to the European Market.

Services

Back-Office

Our Back-Office Service provides companies direct representation in Germany without renting office space or hiring office personnel. We incorporate you locally under the German Law, provide you with a office address, phone lines, establish bank accounts etc. Your German branch is a fully functional enterprise, and our services include providing a sales order desk, making offers to customers, warehousing and shipping, invoicing and collection, book-keeping and your individual reporting.

The Back-Office strategy offers you a direct contact to your customers and minimizes the risk of direct distribution, while reducing the cost of sales to an absolute minimum. Your local legal entity can also serve as a warehouse for your shipments throughout Europe.

Authorized European Representative

Per Article 14.2 of Council Directive 93/42/EEC as amended by Directive 2007/47/EC, manufacturers, without a registered place of business in the EU, require to designate a single Authorized European Representative (AER). Cormedics offers to serve as AER and as of this assists you in meeting your compliance with conformity assessment procedures, serve as primary contact for EU Authorities and support you in incident reporting.

Other Services

  • Assistance in getting regular approvals from ECs and responsible authorities to start clinical trials
  • Development of Reimbursement strategies and their implementation in Germany
  • General consultation on product launching strategies
  • Contact management with clinical key opinion leaders
  • Market Analysis

Jobs

Zur Verstärkung unseres Quality Management- & Regulatory Affairs-Teams suchen wir einen:

Regulatory Affairs Specialist (m/w/d)

    Ihr Aufgabengebiet:

  • Ausarbeitung und Pflege von QM-Prozeduren für unser Handelsunternehmen
  • Begleitung von externen Entwicklungsprojekten
  • Übernahme der QM-relevanten Aufgaben im Unternehmen
  • Unterstützung bei Implementierung und Umsetzung der DSGVO

  • Ihr Profil:

  • Abgeschlossenes Studium der Medizintechnik oder im Naturwissenschaftlichen Bereich mit mindestens 5 Jahren Berufserfahrung
  • Erfahrung in der Entwicklung und Zertifizierung von Medizinprodukten Klassen IIa/b und III
  • Erfahrung in der Erstellung von Technischer Dokumentation
  • Ausgeprägte Kommunikationsfähigkeit, selbstständige, organisierte und lösungsorientierte Arbeitsweise
  • Fundierte Kenntnisse in Standard-IT Programmen, insbesondere in MS-Office-Produkten
  • Sehr gute Englischkenntnisse

  • Was wir Ihnen bieten:

  • Eine interessante, verantwortungsvolle und abwechslungsreiche Tätigkeit in der Medizintechnik
  • Arbeiten in einem Team bei gutem Arbeitsklima
  • Flexible Auswahl des Arbeitsplatzes & Home-Office
  • Attraktive Vergütung

  • Wenn Sie an dieser Herausforderung interessiert sind, freuen wir uns auf Ihre aussagekräftige Bewerbung im pdf Format, inklusive Ihrer Gehaltsvorstellung und dem frühest möglichen Eintrittstermin. Bitte senden Sie diese an info@cormedics.com


    Contact

    Cormedics Medizintechnik GmbH
    Bahnhofstr. 32
    82041 Deisenhofen
    Tel: 089 / 666 58 79-0
    Fax: 089 / 54 999 030
    E-Mail: info@cormedics.com
    Web: www.cormedics.com