Regulatory Affairs Strategy Sr. Associate – Medical Devices

About the role

Alcon’s WaveLight GmbH is seeking a Regulatory Affairs Strategy Sr. Associate to join its Global Regulatory Affairs team in Erlangen. You will support regulatory activities for the WaveLight portfolio, ensuring compliance with global requirements for innovative eye‑care medical technologies.

Key responsibilities

• Develop and support regulatory strategies to obtain and maintain product approvals for the WaveLight portfolio.
• Prepare and coordinate regulatory submissions, including registrations, renewals, and updates, collaborating with internal teams, manufacturing sites, regulatory agents, and health authorities.
• Review promotional materials and labeling for legal, ethical, and industry compliance.
• Maintain accurate technical documentation and dossiers.
• Support product lifecycle activities by assessing regulatory impacts of changes and guiding modification pathways.
• Facilitate cross‑functional and authority interactions, providing regulatory input and addressing country‑specific queries.
• Ensure strict GxP and quality‑system compliance, follow SOPs, document thoroughly, and contribute to audits and inspections.

Required profile

• Degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
• Fluency in English and German (written and verbal).
• 5+ years of experience with global medical device submissions.

Required skills

• EU MDR technical documentation.
• FDA 510(k) and PMA submissions.
• Health Canada Class II & III regulatory processes.
• GxP compliance.