Regulatory Strategy Senior Associate – Medical Devices (German/English)

About the role

Alcon is seeking a Regulatory Strategy Senior Associate to join its Global Regulatory Affairs team in Schaffhausen. You will support regulatory activities for a portfolio of eye‑care medical devices, ensuring products meet global and local requirements while facilitating market access.

Key responsibilities

• Develop and support regulatory strategies to obtain and maintain product approvals worldwide.
• Prepare and coordinate submissions, renewals, and updates in collaboration with internal teams, manufacturing sites, agents, and health authorities.
• Review promotional materials and labeling for compliance with legal, ethical, and industry standards.
• Manage product lifecycle activities, assess regulatory impacts of changes, and guide modification pathways.
• Provide regulatory input to cross‑functional teams, address country‑specific queries, and act as a communication hub.
• Maintain GxP and quality‑system compliance, document activities, and support audits and inspections.

Required profile

• Degree in Life Sciences, Biomedical Engineering, Pharmacy or a related field.
• Fluency in written and spoken English and German.
• 5+ years of experience with global medical‑device submissions (EU MDR, FDA 510(k)/PMAs, Health Canada, ISO).
• Proven ability to take ownership of market submissions and coordinate cross‑functional regulatory activities.

Required skills

• EU MDR technical documentation
• FDA 510(k) and PMA processes
• Health Canada Class II & III submission expertise
• ISO standards compliance
• GxP compliance and quality‑system procedures

What we offer

• Opportunity to work on innovative eye‑care technologies.
• Collaborative, inclusive global environment.
• Career development within a leading eye‑care company.