Regulatory Strategy Lead — Medical Devices

alcon; Schaffhausen; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Alcon is seeking a Regulatory Strategy Sr. Associate in Schaffhausen to support global regulatory activities for our medical device portfolio.

You will contribute to regulatory submissions, ensure compliant materials, and collaborate across teams to keep products aligned with regulatory standards. In this role, you will navigate EU MDR, FDA submissions, and Health Canada classifications while maintaining thorough documentation and timelines.

Qualifikationen

• Degree in Life Sciences, Biomedical Engineering, Pharmacy, or related field.
• Fluency in English and German (written and spoken).
• 5+ years of experience with global medical device submissions.
• Strong attention to regulatory documentation and cross-functional coordination.
• Experience with EU MDR, FDA 510(k)/PMAs, Health Canada Class II/III, ISO.

Aufgaben

• Support regulatory submissions and maintain technical documentation.
• Coordinate with internal teams, manufacturers, regulatory agents, and health authorities.
• Review promotional materials for compliance with legal and industry standards.
• Assist with lifecycle updates and ensure regulatory alignment across products.
• Facilitate cross-functional communication to achieve timely approvals.
• Maintain GxP compliance, SOP adherence, and audit readiness.

Kenntnisse

Fluent English & German

Strong communication skills

Organizational & time management

Attention to detail

Ausbildung

Degree in Life Sciences, Biomedical Engineering, Pharmacy, or related field

Jobbeschreibung

Alcon is seeking a Regulatory Strategy Sr. Associate in Schaffhausen to support global regulatory activities for our medical device portfolio.

You will contribute to regulatory submissions, ensure compliant materials, and collaborate across teams to keep products aligned with regulatory standards. In this role, you will navigate EU MDR, FDA submissions, and Health Canada classifications while maintaining thorough documentation and timelines.