Job RA & QA - Regulatory Affairs and Quality Assurance unspecified Hycel Handelsges.m.b.H. - Jobangebote

Berufsbezeichnung:
RA & QA - Regulatory Affairs and Quality Assurance

Arbeitsbeschreibung:
Hycel, during its long story, has developed, manufactured, and sold a lot of medical devices for In Vitro Diagnostic in the world, especially in Clinical Chemistry (Lisa), in hematology (Celly, Xenia), in immunology (3X3) with associated reagents and controls.

Hycel, since 2012, is an Austrian company located at Vienna/Schwechat. Hycel sells a full complete line of instruments, reagents, and associated accessories, for private laboratories, hospitals and doctor¿s offices.

We are searching for

1 RA & QA - Regulatory Affairs and Quality Assurance

1.Mission

Assure the coverage of regulatory requirements and efficient registration of devices in EU and the rest of the world.

Assure the Quality Management System.

2.Activities

Quality Management System

- Participation in maintaining of Quality Management System.

- Surveillance over documentation of Quality Management System according to ISO 9001:2015 and ISO13485:2016.

Regulatory affairs

- Prepare and maintain all the documents according with the new European regulation.

- Preparation of informative materials regarding Hycel products:

* preparation and updating of instructions, labels and lists of products, information for customersabout new products and other necessary materials, depending on actual needs

* directing material to concerned persons.

- Participation in local and international fairs, seminaries and conventions.

- Collecting information regarding offer of competitive organizations.

- Executing duties regarding registration and Free Sale Certificates, in cooperation with other employees.

- Preparation and cataloguing of CE documentation.

- Preparation documentation for distributors.

- Correspondance with Hycel¿s distributors and suppliers around the world.

- Correspondance, if necessary, with Authorities around the world.

3.General methods

- Promote the understanding and implementation of regulatory requirements.

- Guarding the quality at all levels of functioning Quality Management System.

- Language: German and English¿Could work with a team or alone.

Application:

Hycel Handelsgesellschaft m.b.H.

Herr Dipl. Ing. Walter Vincze

Concorde Business Park 3

2320 Schwechat

E-Mail: wvincze (at) hycel-medical.com

www.hycel-medical.com

Das Mindestentgelt für die Stelle als RA & QA - Regulatory Affairs and Quality Assurance beträgt 2.010,00 EUR brutto pro Monat auf Basis Vollzeitbeschäftigung. Bereitschaft zur Überzahlung.

Wie Sie sich bewerben: Schriftliche Bewerbung

Vertragstyp: contracttohire

Angestelltenname: Hycel Handelsges.m.b.H.