Regulatory Strategy Sr. Associate (m/f/d) - Medical Devices - German & English speaking

The company seeks a Senior Regulatory Strategy Associate to support the Alcon portfolio in Schaffhausen, Switzerland. The role focuses on global compliance, submission coordination, and lifecycle management for medical devices, requiring fluency in English and German.

This position provides essential regulatory guidance across the full product lifecycle for innovative medical technologies. The role ensures that global and local requirements are met from the initial stages of innovation through to successful market launch and ongoing compliance.

Responsibilities

• Develop regulatory strategies to secure and sustain product approvals for the Alcon portfolio, ensuring adherence to international and regional standards.
• Organize and prepare regulatory filings, including registrations, renewals, and updates, by working closely with internal departments, production facilities, external agents, and health authorities.
• Examine promotional content and labeling to verify compliance with legal, ethical, and industry norms, while keeping technical documentation and dossiers current and accurate.
• Evaluate the regulatory effects of product modifications, guide regulatory pathways for changes, and ensure continuous compliance throughout the medical device portfolio.
• Act as a central point of contact for cross-functional teams and health authorities, addressing country-specific questions and providing regulatory insights to expedite approvals.
• Uphold strict compliance with GxP and quality systems by following standard operating procedures, maintaining detailed records, completing mandatory training, and supporting audits and process improvements.

Requirements

• University degree in Life Sciences, Biomedical Engineering, Pharmacy, or a closely related discipline.
• Professional fluency in both English and German, including written and verbal communication.
• Over five years of experience managing global medical device submissions, such as EU MDR technical documentation, FDA 510(k)/PMAs, Health Canada Class II & III, and ISO standards, with a drive to further develop regulatory knowledge.
• Strong attention to detail when handling technical documentation, regulatory filings, and compliance materials.
• Effective communication skills to collaborate with cross-functional teams and interact professionally with regulatory agencies.
• Excellent organizational and time-management abilities to handle multiple tasks, submissions, and deadlines in a structured setting.
• Commitment to quality, including adherence to GxP, SOPs, accurate documentation practices, and continuous learning through required trainings.

What the company offers

• Contribute to the entire product lifecycle, from innovation to market success.
• Collaborate with a dedicated, high-performing team in a dynamic, supportive workplace.
• Join a global leader in medical technology, where your work contributes to life-changing advancements in eye care.

About the company

Alcon is the global leader in eye care, driven by the meaningful work of helping people see brilliantly. The company innovates boldly, champions progress, and acts with speed to make an impact in the lives of patients and customers. Alcon fosters an inclusive culture and seeks diverse, talented individuals to join its mission.

• The company is dedicated to helping people see brilliantly through bold innovation and rapid action.
• Employees are recognized for their commitment and contributions, with opportunities for career growth.
• The team goes above and beyond to make a meaningful impact on patients and customers.
• Alcon fosters an inclusive culture and values diverse, talented individuals.