Senior Regulatory Affairs Specialist 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. In addition, the Regulatory Affairs Senior Specialist is tasked with also leading improvement initiatives to ensure efficiency and effectiveness of the regulatory affairs department's processes, which will help my client navigate complex regulatory environments more easily.
In this role, you will have the opportunity to:
- Generate submissions to ensure regulatory compliance to maintain market approvals.
- Ensure alignment with relevant stakeholders.
- Take part in the RA Regulatory Intelligence process, including monitoring, interpreting, and generating impact assessments of upcoming changes to regulations.
- Lead and execute projects in the Global International Registration team.
The essential requirements of the job include:
- Master's degree, e.g., engineering, biotechnology, pharmaceutical sciences, medical technology, or similar science field.
- At least 10 years' experience in Regulatory Affairs within In vitro Diagnostic Devices or Medical Devices.
- Experience leading projects.
- Experience with cross-functional work.
- Core Team member for complex development or maintenance project, e.g., spanning across a portfolio, rather than a single product.
- Experience with cross-cultural collaboration.
