Regulatory Specialist
HeartFlowSalary not specified
- Full Time
- Junior (1 to 2 years)
Not SpecifiedCompensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Pharmaceuticals, Regulatory AffairsIndustries
Requirements
Candidates should possess a Bachelor’s degree in Technical, Engineering, or Scientific fields, and a minimum of 1 year of experience in Regulatory Affairs or Quality Assurance within the medical device or medicinal products industry. Familiarity with development and manufacturing processes for at least 2 years, along with knowledge of quality management and risk management standards such as ISO 13485 and ISO 14971 is required. Understanding of medical device regulations, including the MDD 93/42/EEC and MDR 2017/745, is also essential.
Responsibilities
The Regulatory Affairs Expert will manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling, ensuring compliance with regulatory standards and testing requirements. They will coordinate regulatory approvals and change notifications with Notified Bodies and Authorities, ensuring global regulatory product availability aligned with commercial strategy. The role involves leading regulatory strategies for FME products, overseeing the preparation of Free Sale Certificates, declarations, and site registrations, as well as coordinating regulatory aspects of product and process changes, including Declarations of Conformity and marketing material reviews.
Skills
MDD 93/42/EEC
MDR 2017/745
ISO 13485
ISO 14971
Medical Device Regulations
Technical Files
Registration Dossiers
IFU
Labeling
Quality Management
Risk Management
Free Sale Certificates
Declarations of Conformity
Marketing Material Reviews
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.
Key Metrics
Waltham, MassachusettsHeadquarters
1996Year Founded
$39.1MTotal Funding
LATE_VCCompany Stage
Biotechnology, HealthcareIndustries
11-50Employees