Regulatory Affairs Manager (Senior) (m/f/d)
Tuttlingen, BW, DE, 78532
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