Coordinate and track day‑to‑day regulatory activities for MedSurg / Apheresis products, ensuring compliance with local and international regulations.
Responsibilities
Coordinate, obtain, notarize, legalize, compile and distribute documentation required to support international regulatory submissions.
Organize, maintain and archive regulatory submission files and records within RIMSys.
Maintain and update product registration metadata in regional and national regulatory databases, including EUDAMED and applicable national databases.
Communicate and coordinate with internal stakeholders, distributors and other external partners regarding regulatory documentation and registration activities.
Contribute to the preparation and maintenance of EU Technical Files and ensure appropriate documentation is stored within the Agile document repository.
Requirements
Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality, Business Administration, or a related field
Coordinate the collection, tracking, review, and maintenance of site regulatory and essential documents to support site activation and ongoing study requirements.
Compensation
The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):
United States of America - $60,000.00 - $119,000.00
Responsibilities
Coordinate the collection, tracking, review, and maintenance of site regulatory and essential documents to support site activation and ongoing study requirements.
Partner with study teams, sites, and functional stakeholders to ensure timely completion of start-up activities and activation milestones.
Review study-specific regulatory documentation, identify gaps or quality issues, and drive corrective actions prior to final approval.
Support the development, adaptation, and review of country- and site-specific informed consent documentation.
Facilitate site identification and feasibility activities, including confidentiality agreements, feasibility questionnaires, and site qualification efforts.
Requirements
Bachelor's degree in medical, biological, physical, health, pharmacy, or another related scientific discipline
Coordinate the collection, tracking, review, and maintenance of site regulatory and essential documents to support site activation and ongoing study requirements.
Compensation
The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):
United States of America - $60,000.00 - $119,000.00
Responsibilities
Coordinate the collection, tracking, review, and maintenance of site regulatory and essential documents to support site activation and ongoing study requirements.
Partner with study teams, sites, and functional stakeholders to ensure timely completion of start-up activities and activation milestones.
Review study-specific regulatory documentation, identify gaps or quality issues, and drive corrective actions prior to final approval.
Support the development, adaptation, and review of country- and site-specific informed consent documentation.
Facilitate site identification and feasibility activities, including confidentiality agreements, feasibility questionnaires, and site qualification efforts.
Requirements
Bachelor's degree in medical, biological, physical, health, pharmacy, or another related scientific discipline
Contributing to Magnetic Resonance Imaging (MRI) pulse sequence development, translating novel concepts into robust product solutions for clinical MR applications.
Compensation
The base salary range for this role is EUR 50,750.00 - EUR 79,750.00. This role is eligible for 3% short term incentive
Responsibilities
Developing, adapting and innovating MR pulse sequences to enable new clinical contrasts and improve image quality, clinical functionality and usability
Bringing clinical MR features from research stage through advanced development to the market
Translating clinical and technical needs into product requirements, prototyping and demonstrating feasibility
Creating software designs aligned with product requirements and software architecture
Engineering concepts into robust product solutions, including implementation, automated testing and verification
Lead teams focused on groundwater and surface water compliance and permitting for solid waste, industrial waste, and coal combustion residual landfills.
Responsibilities
Oversee teams to ensure field efforts, data analysis, and reporting activities are consistent with site‑specific plans and regulations
Mentor, guide, and motivate early career staff
Task and project management including planning, budgeting, and schedule management
Direct geochemical evaluations of groundwater and surface water quality data
Oversee groundwater compliance evaluations and statistical analyses
Requirements
Bachelor’s Degree in Geology, Hydrogeology, Geochemistry, Environmental Engineering, or related field (Masters preferred)
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