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Regulatory Affairs Specialist
The RA Specialist for Radiometer is responsible for ensuring coordination of regulatory activities for a few of our Blood Gas products manufactured in California to help ensure continued compliance in all markets.
In this role, you will have the opportunity to:
- Facilitate coordination of regulatory activities between California and Denmark for design control activities and international registrations for a few of the instruments/consumables manufactured in our California site.
- Ensure compliance with EU regulations.
- Generate STED files, international submissions & assess design changes.
- Plan and execute projects for new regulatory requirements.
Senior Regulatory Specialist
The Senior Regulatory Affairs Specialist at Radiometer is responsible for collecting and generating documentation for product submissions to ensure compliance with international regulations. This role is critical for ensuring that Radiometer's products can be sold in markets around the world.
If you thrive in a fast-paced environment, are used to playing a critical supporting role and want to work in a world-class efficient team that is part of a Global RA department and have interactions and stakeholders to connect with in a global scale - read on.
Regulatory Affairs Manager
The Regulatory Affairs Manager at Radiometer is responsible for managing the preparation and submission of the required documentation for product registration, approval, and compliance with international regulations.
This role is critical for ensuring that Radiometer's products can be sold in markets around the world. You will have the opportunity to:
- Ensure regulatory compliance to maintain market approvals
- Lead a team of skilled RA associates
- Ensure alignment with relevant stakeholders
QA Specialist
You will be responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms.
You will have the opportunity to:
- Provide Design Control guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
- Represent Quality Assurance in design and development projects and in cross-functional teams supporting new product development.
