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Open nowPosted 3 days ago

Head Regulatory Affairs Medizintechnik

job-room.ch94,443 open roles

Where
St. Gallen, SG, Switzerland
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Your applicationOpen nowHead Regulatory Affairs Medizintechnikjob-room.ch · St. Gallen, SG, Switzerland

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The clock on this job

Early applications get read.

8.2% of postings close within 7 days. Measured by our own scanner across the market. job-room.ch postings stay open a median of 2 days.

Share of postings closed within
  1. 1.8%1 day
  2. 3.6%3 days
  3. 8.2%7 days
  4. 15.2%14 days
  5. 34.0%30 days
This job: posted 3 days ago

job-room.ch median: 2 days open

The posting

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Head Regulatory Affairs Medizintechnik (m/w) ============================================

Top\-Produkte \& intelligente digitale Lösungen.

Sind Sie eine Person, die gerne Lösungen sucht, um einen guten Rahmen für Produktneuheiten und Zulassungen zu schaffen? Dann gibt es ein führendes Schweizer Medizintechnikunternehmen in der Region Ostschweiz, welches Sie unbedingt kennenlernen möchte. Der global tätige Hersteller vertreibt technisch hochstehende Geräte und Instrumente für die Chirurgie. Die Firma verbindet die Werte Qualität, Kontinuität und Zuverlässigkeit mit Dynamik, Pioniergeist und Innovation. Region: Ostschweiz.

Darauf können Sie sich freuen:

  • Spannende, abwechslungsreiche Tätigkeit mit Freiraum für Ideen und Eigeninitiative
  • Erfolgreiches Schweizer KMU im internationalen Umfeld und in der innovativen Healthcare\-Branche
  • Attraktive und flexible Arbeits\- und Anstellungsbedingungen

Ihr Verantwortungs\- und Aufgabenbereich:

  • Disziplinarische und fachliche Führung sowie Unterstützung der Mitarbeiter RA
  • Planung, Koordination und Abschluss regulatorischer Aktivitäten (MDR 2017/745 und andere Standards) und internationaler Zulassungsverfahren für aktive und nicht\-aktive Medizinprodukte in der Schweiz, Europa, USA, CSA und Asien
  • Zusammenarbeit mit der Entwicklungsabteilung
  • Erstellung von technischen Dokumentationen für Medizinprodukte sowie Anpassung bestehender Dokumentationen
  • Unterstützung von Quality\-Management\-Initiativen und Usability\-Studien sowie Mitarbeit im Change\-Management
  • Fachliche Führung in interdisziplinären Projektteams zur Produktzulassung als Vertreter der Abteilung Regulatory Affairs
  • Pflege und Überprüfung der technischen Produktakten auf die gesetzlichen Anforderungen

Ihr Profil:

  • Erfolgreich abgeschlossene höhere technische oder naturwissenschaftliche Ausbildung auf Stufe FH oder Uni
  • Berufs\- und erste Führungserfahrung in der Medizintechnik und im Bereich Regulatory Affairs
  • Erfahrung in der Erstellung von technischer Dokumentation und in der Erstellung von Zulassungsdokumenten
  • Aktuelle Kenntnisse der normativen und regulatorischen Anforderungen an Medizinprodukte
  • Sehr gute Deutsch\- und Englischkenntnisse

Kontakt

Rufen Sie uns an oder senden Sie Ihre Bewerbungsunterlagen unter Angabe der Referenznummer JB\-211. und Weisflog freuen sich, Sie persönlich kennenzulernen.

![ Consulting AG]( )

* Consulting AG Rue Centrale 9 1003 Lausanne

*

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