Regulatory Affairs Expert at Fresenius Medical Care

Oberdorf, Basel-Landschaft, Switzerland

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, PharmaceuticalsIndustries

Requirements

Expertise in Drug Safety as PvRP (Pharmacovigilance), Local Drug Regulatory Affairs, and Good Distribution Practice (FVP/RP) in Switzerland and Austria

Responsibilities

Execute RA activities in line with defined procedures and processes (LDRA)
Obtain product registration dossiers from HQ Q&R and tailor them to meet country/region registration requirements (LDRA)
Implement processes involved with maintaining annual licenses, registrations, and listings (LDRA)
Submit notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use (LDRA)
Support and accelerate market access for products in line with regulatory requirements, verticals, and commercial operations roadmap (LDRA)
Contribute to due diligences for in-licensing projects and to the preparation of launches for new development projects for all regulatory aspects (LDRA)
Serve as the Regulatory point of contact on assigned tasks with local/regional management and/or at internal meetings, providing global regulatory strategic recommendations and risk assessments (LDRA)
Monitor, evaluate, and inform key internal stakeholders about applicable national and hub regulatory requirements; coordinate internal implementation and contribute to the development of new regulatory requirements (LDRA)
Perform all regulatory affairs activities in the hub, including management of product complaints and product regulatory conformity, safety, and post-market systems, as well as communication to applicable SysQaRa functions in accordance with corporate SOPs (LDRA)
Perform based on established targets, KPIs, and objectives for Q&R (LDRA)
Perform regular Pharmacovigilance processes and activities (including trainings) (PVRP)
Ensure that adverse events and product quality complaints are reported in compliance with corporate policies and procedures (PVRP)
Lead the strategic planning and implementation of pharmacovigilance objectives in your country/region, including department structure, processes, and local Health Authority policy implementation (PVRP)
Maintain the filing, storage, and archiving of safety-related documentation in accordance with company policies and local requirements (PVRP)
Ensure audit/inspection readiness, coordinates, leads, and actively participates in local audits and inspections (PVRP)
Support Pharmacovigilance Agreements, when applicable (PVRP)
Ensure that a Quality management system is implemented and maintained (FVP/GDP RP)

Skills

Pharmacovigilance

PvRP

Local Drug Regulatory Affairs

LDRA

Good Distribution Practice

FVP/RP

Product Registration

Dossier Management

Regulatory Compliance

Annual Licenses

Supplemental Dossiers

Fresenius Medical Care

Provides dialysis and renal healthcare services

About Fresenius Medical Care

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.

Waltham, MassachusettsHeadquarters

1996Year Founded

$39.1MTotal Funding

LATE_VCCompany Stage

Biotechnology, HealthcareIndustries

11-50Employees

Benefits

Professional Development Budget

Conference Attendance Budget

Flexible Work Hours

Risks

Increased competition from telehealth solutions like Philips' eCareManager 4.1.

Rising mental health challenges may impact FMCNA's employee productivity.

Virtual reality education may face adoption and accessibility challenges in rural areas.

Differentiation

FMCNA is the world's largest fully integrated renal company.

FMCNA offers a comprehensive line of dialysis equipment and renal pharmaceuticals.

FMCNA provides coordinated healthcare services at pivotal care points for chronic conditions.

Upsides

Telehealth market growth supports FMCNA's remote patient monitoring services.

Home dialysis market expansion aligns with FMCNA's patient-centric care approach.

AI integration enhances FMCNA's predictive analytics and personalized medicine capabilities.

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