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

Job Description

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