Ihre Aufgaben
- Plan and update on global regulatory strategy for product submissions
- Perform impact assessment on project roadmap and project activities
- Collaborate with cross-functional teams to develop comprehensive regulatory plans.
- Monitor regulatory trends and predict potential impacts on current and future projects.
- Analyze past submission outcomes to identify areas for improvement.
- Develop and implement strategies to enhance the quality and efficiency of regulatory submissions.
- Share best practices and lessons learned across the regulatory affairs team to foster continuous improvement globally
- Participate in relevant boards (e.g. change board or project boards) to address regulatory changes
- Conduct regulatory risk assessments and develop mitigation strategies on portfolio
- Support Interpretation and implementation of new regulatory requirements and guidelines with crossfunctional departments (e.g. Regulatory Operations, R&D and others)
- Support Development and updating of internal processes and procedures to ensure compliance with current regulatory standards.
Ihre Qualifikationen
- A degree in Medical Engineering or a related field
- At least 3-5 years of experience in respective field
- Experience in international markets
- Excellent written and verbal communication skills in English (additional language skills are an advantage)
- Ability to present complex topics clearly and persuasively
- Strong teamwork skills and the ability to work effectively with different departments and external partners
- Strong analytical skills to assess data and identify opportunities for project optimization
- Solution-oriented mindset for quick and effective problem-solving during project execution
Ihre Vorteile
-30 days of annual leave
-Up to 60% mobile work possible + flexible work time model with overtime compensation
-Holiday and Christmas bonuses
-Corporate benefits discounts for employees
-Comprehensive company pension scheme and capital-forming benefits
-Company restaurant with live cooking and healthy food (subsidized)
-Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
-Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
-Various subsidized company sports groups and access to the inhouse company gym