Regulatory Affairs Manager (m/f/d)
KARL STORZ Endoscopy America, Inc.
Your Mission You support the “Imaging” product line throughout its entire lifecycle Coordinating and creating technical documentation for the assigned medical device groups is part of your responsibilities You identify global regulatory requirements for the assigned medical device groups Developing testing and approval strategies for global distribution is one of your tasks You continuously analyze and optimize processes Monitoring regulatory compliance throughout the entire product lifecycle is part of your role You work closely with development teams from other departments and ensure that they receive targeted training on regulatory requirements Your Talents Completed scientific or technical studies Several years of professional experience in the field of regulatory affairs for active medical devices Knowledge of the relevant product standards Expertise in the field of medical devices, especially in the area of endoscopy/imaging and electrical safety desirable Confident manner in international project structures Strong communication skills and independent working style Very good knowledge of German and English Your Benefits Flexible working hours & mobile working: In many areas, working hours and location can be arranged as required 30 vacation days and various special payments Further training opportunities: Open in-house seminar program, extensive e-learning offering, professional development courses and much more Corporate benefits and bicycle leasing Subsidy for private pension plan and company health management Various childcare options – at the headquarters in Tuttlingen Health, sports, cultural and leisure activities – offers vary depending on location
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