Regulatory Affairs Specialist - Heidelberg, Deutschland - Adaptive Life Science

Adaptive Life Science
Adaptive Life Science
Geprüftes Unternehmen
Heidelberg, Deutschland

vor 3 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung
_Are you passionate about bringing safe and effective medical devices to market with speed and agility?_


My client, a global leader in the design, manufacture, and distribution of cutting-edge mobility devices is seeking a promising Regulatory Affairs Specialist to join their European team.


  • Ready to put your skills to work?_

Your tasks:


  • Implement quality system components focused on regulatory compliance with MDR 2017/745, ISO 13485 and ISO 1497
  • Manage projects and activities for the improvement of products and processes from a regulatory standpoint
  • Monitor and ensure the compliance of regulatory requirements (Europe, Switzerland & UK)
  • Manage CAPA system, track recalls and FSCAs
  • Participate in risk assessment activities such as UFMEA
  • Collaborate with the Quality Director Europe to ensure documentation is compliant
  • Assist in liability claim investigation and document collection

Your profile:


  • Fluent in English at least intermediate knowledge of German
  • 2+ years professional experience in regulatory affairs or quality management relating to medical devices
  • Thorough knowledge of regulatory requirements (eg MDR, ISO 13485 & ISO 14971)
  • Computer proficiency with MS Office
  • Strong communication skills, good organizational skills, analytical thinking and a high level of reliability

Art der Stelle:
Vollzeit, Festanstellung

Gehalt: 60.000,00€ ,00€ pro Monat


Arbeitszeiten:

  • Montag bis Freitag

Leistungen:

  • Betriebliche Weiterbildung
  • Flexible Arbeitszeiten
  • Homeoffice-Möglichkeit

Möglichkeit zu pendeln/umzuziehen:

  • Heidelberg: Problemlos pendeln oder Bereitschaft, mit Unterstützung durch den Arbeitgeber umzuziehen (Erforderlich)

Bewerbungsfrage(n):

  • Have you worked on Risk Management processes (CAPAs, FSCAs and Recalls) before?

Berufserfahrung:

  • Regulatory Affairs for
Medical Devices: 2 Jahre (Erforderlich)


Sprache:

  • German (Erforderlich)

Arbeitsort:
Vor Ort
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