Regulatory Affairs Specialist (f/m) Medical Devices

Ort

Ecolab-Allee 1, 40764 Monheim am Rhein, Deutschland

Unternehmen

Ecolab

Jetzt per App bewerben

Basisinfos

Unternehmen
Ecolab
Ort
Ecolab-Allee 1, 40764 Monheim am Rhein, Deutschland
Funktion
Naturwissen- schaften und Forschung, Ingenieure und technische Berufe
Erfahrung
Mit Berufserfahrung
Sektor
Medizintechnik, Chemie- & Erdölverarbeitende Industrie, Pharmaindustrie
Anstellungsart
Feste Anstellung
Arbeitszeit
Vollzeit

Aufgabenbeschreibung

  • Work with the regulatory agencies in EMEA and third-party accreditation bodies to ensure compliance of Ecolab with current and future regulatory requirements
  • Lead the vigilance process, fulfil incident reporting obligations and prepare related documents and follow-up
  • Support the business with profound knowledge in the affected harmonized standards and other regulatory guidance documents
  • Monitor and analyse regulation changes to ensure continued compliance
  • Devices Regulatory Affairs or Quality Management for Medical Devices German Medical Device Law, EU Medical Device Regulation 2017/745, MDD 93/42 and familiarity with harmonized standards such as EN ISO 13485, EN ISO 14971 or MEDDEV guidelines
  • Demonstrated success in managing processes and projects self-reliantly and managing challenges as the accountable project
  • collaborate with internal and external stakeholders on an international and virtual base combined with an analytical and solution oriented working manner
  • Complementary access to our in-house-gym, massage chairs and parking lot
  • Coffee-connect-areas, company canteen and think tanks

Detailinfos

Geforderte Fähigkeiten

  • MS Office
  • Regulatory Affairs
  • Natural Sciences
  • Engineering
  • Medical Devices
  • Quality Management
  • MDR
  • EN ISO 13485
  • EN ISO 14971

Geforderte Talente

  • communication
  • Intercultural collaboration
  • prioritizing
  • project management

Sprachen

  • English
  • German

Ecolab Deutschland GmbH

A trusted partner at more than one million customer locations, Ecolab (ECL) is the global leader in water, hygiene and energy technologies and services that protect people and vital resources. With 2015 sales of $13.5 billion and 47,000 associates, Ecolab delivers comprehensive solutions and on-site service to promote safe food, maintain clean environments, optimize water and energy use and improve operational efficiencies for customers in the food, healthcare, energy, hospitality and industrial markets in more than 170 countries around the world. For more Ecolab news and information, visit www.ecolab.com.

Kontaktperson

Mona Schauer
Talent Acquisition Specialist
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