Regulatory Affairs Manager (Senior) (m/f/d)
KARL STORZ Endoscopy America, Inc.
Your Mission You will prepare and compile regulatory submission dossiers for new medical device registrations and changes to existing products, in accordance with regulations Monitoring new legislations, policies, standards and guidelines that affect the assigned product portfolio will be one of your tasks The collaboration with cross-functional teams to collect necessary information is a daily mission for you You will conduct post-market surveillance and report adverse events/ field safety corrective actions to the authorities In your role you will be supporting currently marketed products, e.g, review engineering changes, product labeling and promotional materials We want you to initiate and manage projects for continous improvement and compliance with regulatory requirements You will report to the manager and relevant stakeholder on key results, serious incidents, as well as potential opportunities and risks for the company
Your Talents Master of Science or Master of Engineering, specializing in medical devices or a related field At least 5 years of professional experience in this or a comparable position Knowlege of SAP user interfaces like PLM and Easy DM, alsing with familiarity with MS Project Proficient in MS Office Strong service and customer orientation Flexibility to adapt to various situations and personalities Ability to work independently Fluent in written and spoken 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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