Full-Time
Regulatory & Quality Compliance Manager
m/f/d
Confirmed live in the last 24 hours
Fresenius Medical Care
11-50 employees
Provides dialysis and renal healthcare services
Mid, Senior
Knoxville, TN, USA + 1 more
More locations: Waltham, MA, USA
Opportunity to work on a mobile basis.
- Successfully completed technical or scientific studies
- Experience in project management respectively change control process
- Experience in regulatory affairs or in a quality environment, ideally in a pharmaceutical/medical environment of advantage
- Knowledgeable in relevant regulations (such as registration of medicinal products, change control, GxP, EU requirements, CMC, ICH M4, etc.)
- Language requirements: Fluent in English, advanced in German
- Structured and independent way of working
- Strong communication skills
- Ability to work in and with a team
- Assertiveness
- Support as regulatory expert development and new registration projects (Medicinal Products)
- Project management for the implementation of projects to comply with regulatory requirements
- Organization of submission-readiness of regulatory documentation (e.g., CMC relevant parts)
- Organize and support global creation and maintenance of regulatory documentation
- Management of global teams within change projects
- Expert and interface function to the development department, marketing, production, quality department, as well as to the regional/local approval unit
- International coordination and communication in a global organization
Fresenius Medical Care North America focuses on delivering high-quality healthcare services to individuals with kidney and other chronic conditions. The company operates a vast network of dialysis centers and outpatient labs for cardiac and vascular care, ensuring coordinated treatment for many patients across the continent. It stands out as the largest fully integrated renal company, providing not only dialysis services but also specialty pharmacy and laboratory services. Additionally, Fresenius manufactures and distributes a wide range of dialysis equipment, disposable products, and renal pharmaceuticals. The goal of Fresenius Medical Care is to enhance the quality of life for patients with chronic illnesses by providing comprehensive and accessible healthcare solutions.
Company Stage
N/A
Total Funding
$39.1M
Headquarters
Waltham, Massachusetts
Founded
N/A
6 month growth
↑ 0%1 year growth
↑ 0%2 year growth
↑ 0%
Simplify's Take
What believers are saying
- FMCNA's leadership in the renal care market provides employees with a stable and reputable work environment.
- The company's innovative initiatives, such as the virtual reality kidney education program, demonstrate a commitment to leveraging technology for patient care.
- Recognition from Newsweek and other organizations highlights FMCNA's positive workplace culture and investment in employee development.
What critics are saying
- The highly regulated healthcare industry could pose compliance challenges and impact operational flexibility.
- Dependence on government grants and funding, as seen with the Mississippi Department of Health grant, may introduce financial uncertainties.
What makes Fresenius Medical Care unique
- Fresenius Medical Care North America (FMCNA) is the world's largest fully integrated renal company, offering a comprehensive line of dialysis equipment, disposable products, and renal pharmaceuticals.
- Their extensive network of dialysis facilities and outpatient cardiac and vascular labs provides coordinated healthcare services at pivotal care points, setting them apart from competitors.
- FMCNA's commitment to employee well-being and professional development has earned them a spot on Newsweek's 100 Most Loved Workplaces for two consecutive years.
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