Quality & Regulatory Specialist at Fresenius Medical Care

Stockholm, Stockholm County, Sweden

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DialysisIndustries

Requirements

Scientific education such as Degree in Medicine, Pharmacy, Biology, Chemistry or similar
2-5 years of professional experience in quality management of medical devices or medicinal products respectively similar activity in the regulated environment
Communicative, reliable, careful, conscientious, quality minded, detail oriented, solution-oriented, proactive, analytical and problem-solving skills
Highly professional attitude characterized by a result, quality, patient and customer oriented working style
Functional knowledge of Structure of Quality Management System, ISO 9001 / ISO 13485, MDR, Good Distribution Practice (GDP)
Microsoft Office, QTrak skills
Fluent Swedish and English
Good regulatory understanding
Good communication skills

Responsibilities

Implementation and maintenance of the local Quality Management System in cooperation with the Nordic and BeNeLux Quality Team
If applicable, modification / adaption of Corporate requirements according to national / local needs
If applicable, creation of local instructions according to national requirements
Establishing, implementation, maintenance and improvement of processes
Tracking of CAPA
Maintenance of a documentation management system
Assist Quality Manager and Responsible Person (RP) as contact partner for audits by the Notified Body, Health Authorities or Corporate functions
Contact partner for information to be given to national competent Authorities (FSCA, Recall, etc.) in cooperation with Nordic Quality Team and RP
Tracking, follow up and closure of complaints via QTrack. Share applicable information with Quality Manager and RP
Preparation of Management Review in cooperation with the Nordic Quality Team
Qualification and maintenance of critical suppliers, in cooperation with Procurement, Nordic Quality Team and RP
Training activities, e.g. Quality introduction for new employees
Performance of self-inspections/internal audits in cooperation with Nordic Quality Team
Monitoring of national requirements for medical devices

Skills

Quality Management System

Medical Devices Regulations

EU Regulations

Regulatory Compliance

Process Implementation

Post-Market Surveillance

Continuous Improvement

Data Governance

QMS Maintenance

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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