At Alcon, we are driven by meaningful work to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. You’ll be recognized for your commitment and contributions and see your career like never before. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. In this impactful role, you’ll support regulatory activities for the Alcon portfolio, helping navigate global requirements for innovative medical technologies and playing a key part in bringing safe, high-quality solutions to patients worldwide.
Tasks
- Contribute to regulatory strategy development by supporting activities that help obtain and maintain product approvals for the Alcon portfolio, ensuring alignment with global and local requirements.
- Prepare and coordinate regulatory submissions, including registrations, renewals, and updates, by collaborating with internal teams, manufacturing sites, regulatory agents, and health authorities.
- Review promotional materials and labeling to ensure compliance with legal, ethical, and industry standards, while maintaining accurate and up-to-date technical documentation and dossiers.
- Support product lifecycle activities by assessing regulatory impacts of changes, assisting with regulatory pathways for modifications, and ensuring continuous compliance across the medical device portfolio.
- Facilitate cross-functional and authority interactions by providing regulatory input, addressing country-specific queries, and serving as a key point of communication to help ensure timely approvals.
- 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.
Requirements
- Degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field
- Fluency in English and German (both written and verbal)
- 5+ years of experience working with global medical device submissions (e.g., EU MDR technical Documentation, FDA 510(k)/PMAs, Health Canada Class II & III, ISO), with a strong motivation to continue expanding regulatory expertise
- Hands-on experience in Regulatory Affairs, ready to take on greater ownership of key market submissions and cross-functional regulatory coordination
- Ability to work with technical documentation, regulatory submissions, and compliance-related materials with strong attention to detail
- Solid communication skills to collaborate effectively with cross-functional teams and interact professionally with regulatory agencies
- Strong organizational and time-management abilities to support multiple tasks, submissions, and deadlines in a structured environment
- Commitment to quality, including adherence to GxP, SOPs, accurate documentation practices, and continuous learning through required trainings
Benefits
- Play a key role in 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
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Über uns
Das Team
Join a dedicated, high-performing team within the Global Regulatory Affairs Team in Schaffhausen, collaborating across functions in a dynamic and supportive workplace.