Regulatory Affairs Specialist (German)

About the role

Alcon is seeking a Regulatory Affairs Specialist with strong German language skills to support the marketing and compliance of its eye‑care medical devices and medicinal products. The role ensures that all products placed on the market meet current pharmaceutical and medical‑device regulations and corporate policies.

Key responsibilities

• Manage regulatory activities for vision‑care and ophthalmic‑surgery devices, including contact lenses, care solutions, visualization equipment, irrigation solutions, viscoelastics and micro‑invasive surgery products.
• Approve and coordinate translation processes for labeling, packaging and complex device documentation.
• Collaborate with the Vision Care affiliate in Aschaffenburg on product‑related matters.
• Support lifecycle management of medicinal products: prepare and submit variations, marketing‑authorisation renewals and PSURs.
• Review chemical‑pharmaceutical documentation, revise packaging texts, patient leaflets and product‑characteristic summaries.
• Coordinate safety‑labeling updates for products marketed in Germany and monitor KPI compliance.
• Handle clinical‑investigation submissions, correspondence, deficiency letters and final study reports for medical devices.
• Ensure accurate product information in national compendia (Rote Liste, Pharmindex, self‑medication list) and review promotional materials for regulatory compliance.

Required profile

• Proven independence and initiative in a regulatory environment.
• Very good knowledge of pharmaceutical and medical‑device law, including AMG, HWG, MPDG and MDR.
• Strong German language proficiency for translation and communication.
• Experience with regulatory submissions, labeling, and safety‑labeling updates.

Required skills