Job Opportunity
We are seeking an experienced Regulatory Affairs Operations professional to join our global team in Heidenheim, Germany. As a key member of our Division Risk Prevention team, you will play a critical role in ensuring product quality and regulatory compliance.
Responsibilities
* Collaborate with cross-functional teams to ensure timely implementation of products according to regulatory requirements.
* Assume portfolio responsibility for products under your care, ensuring compliance throughout the lifecycle.
* Monitor and improve global regulatory product documentation and conformity assessments.
* Drive the optimization of IT infrastructure related to regulatory documentation management.
* Provide strategic consulting on regulatory issues, evaluating product-related regulatory requirements with a focus on risk management, labeling, and post-market surveillance.
* Support complaint management.
Qualification Requirements
* Bachelor's degree in science or technical sciences.
* Professional experience in the medical device environment or another regulatory field of work.
* Proven experience with MDR and ISO 13485.
* Familiarity with FDA regulations and guidelines is desirable.
* Strong interest in electronic regulatory document control and management systems and associated processes.
* Excellent communication skills and open attitude when collaborating with both internal and external partners.
* IT affinity and proficiency with MS Office.
* Fluent written and spoken German and English.