Regulatory Affairs Specialist - Biological Evaluation (f/m/d) in Heidenheim an der Brenz

Jobbeschreibung

Responsibilities: Interpret ISO 10993 requirements and evaluate outcomes considering device factors, intended use, and scientific knowledge Create biological evaluation plans/reports and coordinate biological testing with external labs and Toxicologists Support the development of biological strategy Assistance to representatives of the Business Division and HARTMANN in working groups related to changes in legislation or standards Establish and maintain contacts with testing institutes and external service providers Collaborate with departments like R&D, Manufacturing Engineering and Procurement to ensure biological evaluations comply with EN ISO 10993 Assess biocompatibility of materials, support product registration, and contribute to risk analysis and clinical evaluation reviews Qualifications: Degree in natural science, life science or engineering Knowledge in scientifc and/or clinical working (e.g. Chemical, microbiological or quality lab) Knowledge in the field of medical devices, regulatory affairs or quality management desired Willingness to learn about new technologies and materials Analytical, organizational and communication skills Fluency in German and English Benefits: Flexible working conditions, such as flexible working hours and mobile working Attractive ways of combining work and family life, e.g. Childcare subsidy 30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement Company pension plan with attractive employer contribution incl. Matching model for deferred compensation Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop Access to over 6000 fitness and yoga studios, swimming pools as well as Crossfit and bouldering halls (EGYM Wellpass) Various health and fitness offers, e.g. Skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc. Job Bike Leasing Attractive discounts on e.g. Travel, fashion and technology via our corporate benefits platform

Extra Informationen

Status

Offen

Ausbildungsniveau

Hochschule/Universität

Standort

Heidenheim an der Brenz

Jobart

Vollzeitstelle (mit Erfahrung)

Veröffentlicht am

19-11-2024

Tätigkeitsbereich

Pflege / Betreuung / Babysitting

Führerschein erforderlich?

Nein

Auto erforderlich?

Nein

Motivationsschreiben erforderlich?

Nein

Sprachkenntnisse

Deutsch