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

Posted 12 days 10 hours ago by PAUL HARTMANN AG

Permanent

Not Specified

Other

Bayern, Heidenheim, Germany, 91719

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