Director Regulatory Information Management
vor 6 Monaten
**In your role as** Director Regulatory Information Management (M/F/d) you will be responsible for provision of information on regulatory status (registrations) for all Care Enablement products including regulatory KPIs.
**Your assignments**
- Implementation and maintenance of a registration information management system (RIMS) including a process to steer and control registration activities world-wide (e.g., workflow-based) in accordance with pre-agreed roadmaps
- Owner of FMEs worldwide registration process for medical devices
- Regulatory strategy, portfolio and resource management:
- Definition and alignment of regulatory strategies for all Care Enablement (FME’s medtech company including production) products and systems
- Provision of regulatory input to portfolio management process and coordination of needed actions
- Inform country RA organizations concerning roadmaps of business units (In-Center, Home and Critical Care) and prioritization support as well as active resource management support
- Provision of digital overview on running regulatory projects including status
- Support business units by creating and provisioning central documents needed for registrations including notarization, apostillation, or embassy certifications
**Your profile**
- Successfully completed Master studies in engineering or natural science, similar field of specialization
- Additional qualification such as RA manager training courses
- Strong expertise in RA and global regulatory requirements. Several years of comprehensive leadership experience with familiarity of leading diverse teams in global (matrix) environments; thereof minimum 5 years in RA or Quality Management
- Comprehensive experience and proven track record in handling new developments, product registrations and maintenance of products
- Strong project management skills, highly structured and systematic working style
- Excellent knowledge of FME business and products; ability to interact with all management levels to influence positive change
- Experience with introduction, maintenance, and usage of RIMS software, e.g., IQVIA rim smart, Veeva Vault RIM, Rimsys, etc.
- Willingness to continuously learn and adapt to changing environments
- Fluent in business English, German language is an advantage, further languages are a plus, e.g., Spanish
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