Ihr Aufgabengebiet
- Strategic management and leadershop of the Regulatory Information Management team of four individuals.
- Tasked with providing data on regulatory compliance (registrations) for all Care Enablement products, including monitoring regulatory performance indicators.
- Overseeing the setup and management of a Registration Information Management System (RIMS), incorporating a workflow-driven approach to guide and oversee worldwide registration activities in accordance with predetermined plans.
- Leading the global registration process for medical devices within the organization.
- Crafting and aligning regulatory strategies for all Care Enablement products and systems, including resource allocation management.
- Supplying regulatory insights to the portfolio management process and orchestrating the necessary measures.
- Keeping regional Regulatory Affairs teams informed about business unit roadmaps (In-Center, Home, and Critical Care), extending support in prioritization, and actively managing resource allocation.
- Furnishing a digital overview of ongoing regulatory initiatives, encompassing their current status.
- Aiding business units in creating and providing essential documents required for registrations, encompassing notarization, apostillation, or embassy certifications.
Ihr Hintergrund
- Successful completion of Master’s studies in engineering or a related natural science field.
- Demonstrated expertise in the field of Regulatory Affairs (RA) and comprehensive knowledge of global regulatory requirements.
- Minimum of five years of leadership experience, including managing diverse teams in a global matrix environment
- Proven track record and extensive experience in handling new product developments, product registrations, and product maintenance.
- Strong project management skills, characterized by a highly structured and systematic working style.
- Familiarity with the introduction, maintenance, and utilization of Regulatory Information Management Systems (RIMS) software, such as IQVIA rim smart, Veeva Vault RIM, Rimsys, etc.
- Outstanding stakeholder management and communication skills, facilitating transparent dialogues and effectively addressing conflicts.
- A commitment to continuous learning and the ability to adapt to evolving environments.
- Proficiency in business English, and knowledge of the German language is advantageous. Proficiency in additional languages, such as Spanish, is a plus.
Ihre Benefits
- Meaningful Career: Your work directly contributes to enhancing the quality of life for patients across the globe, making your career exceptionally rewarding.
- Long-Term Account: Enjoy the flexibility of a long-term account that provides various leave options, whether it’s for pursuing further education, taking care of family members, planning for early retirement, or simply taking a break when needed.
- Retirement Benefits: In addition to your salary, you’ll receive valuable employer-sponsored retirement benefits, ensuring financial security for your future.
- Childcare Support: If you have children, you can apply for a monthly financial childcare support allowance, which supplements your income and eases the financial burden of raising a family.
- Workplace Health: Prioritize your well-being with access to a wide range of workplace health programs, including sports activities, nutrition training, and preventive health offerings to keep you at your best.
- Direct Insurance: Fresenius assists you in establishing a direct insurance plan, offering attractive terms through our group contract, providing peace of mind for unexpected circumstances.
- Hybrid Work: Embrace flexibility with various options for hybrid work arrangements. You can choose to work from the comfort of your home, in the office, or a combination of both, allowing you to tailor your work environment to suit your needs and preferences.
Gender-Hinweis
Aus Gründen der besseren Lesbarkeit
wird auf die gleichzeitige Verwendung
der Sprachformen männlich, weiblich
und divers (m/w/d) verzichtet.
Sämtliche Personenbezeichnungen
gelten gleichermaßen für alle
Geschlechter.
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Zuletzt aktualisiert am 19.04.2024