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

Regulatory Strategy Sr. Associate (m/f/d)

Location:

Schaffhausen.

• 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, 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.

• 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 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.

• 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.

For more information, visit Alcon Careers "See your impact" under