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
Support regulatory activities for the Wavelight portfolio, helping navigate global requirements for innovative medical technologies
Job Summary
Support regulatory activities for the Wavelight portfolio, helping navigate global requirements for innovative medical technologies.
Prepare and coordinate regulatory submissions, including registrations, renewals, and updates, by collaborating with internal teams, manufacturing sites, regulatory agents, and health authorities.
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
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
Cross-functional team collaboration
Nice-to-have
Innovative laser systems
Patient impact
Inclusive culture
High-quality solutions
Key Requirements
5+ years of experience with global medical device submissions
Fluency in English and German
Degree in Life Sciences, Biomedical Engineering, Pharmacy, or related field