Regulatory Affairs Manager (Senior) (m/f/d)

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, as well as familiarity with MS Project  
• 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​