Regulatory Affairs Strategy Sr. Associate (m/f/d) – Medical Devices
Alcon
Erlangen, Germany
Global medical device submissions
Regulatory strategy development
Promotional materials and labeling review
You’ll support regulatory activities for the Wavelight portfolio, helping navigate global requirements for innovative medical technologies
Job Summary
You’ll support regulatory activities for the Wavelight portfolio, helping navigate global requirements for innovative medical technologies.
In this impactful role, you’ll contribute to regulatory submissions, ensure compliant promotional materials, assist with lifecycle updates, and collaborate across teams to keep products aligned with regulatory standards.
Maintain strict compliance with GxP and quality systems by following SOPs, keeping thorough documentation, completing required training, and contributing to audits, inspections, and ongoing process improvements.
Matching Summary
You’ll support regulatory activities for the Wavelight portfolio, helping navigate global requirements for innovative medical technologies.
Skills & Requirements
Must-have
Global medical device submissions
Regulatory strategy development
Promotional materials and labeling review
Product lifecycle management
GxP and quality systems compliance
Nice-to-have
Innovative laser systems
Cross-functional collaboration
Patient and customer impact
Inclusive culture
Key Requirements
Degree in Life Sciences, Biomedical Engineering, Pharmacy, or related field
5+ years of experience with global medical device submissions
Fluency in English and German (written and verbal)