Regulatory Affairs Specialist - Biological Evaluation (f/m/d)
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
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