Local Safety Officer – 1 Year Contract

About the role

Roche is seeking a detail‑oriented Local Safety Officer to ensure compliance, documentation, and safety reporting for its Czech operations. You will act as the bridge between global standards, local authorities such as SÚKL, and internal teams, supporting both customer‑facing and internal activities.

Key responsibilities

• Maintain ISO 9001 documentation, SOPs and internal directives, and prepare for QM audits.
• Serve as the primary contact for Safety Board matters, local regulatory bodies, and field safety corrective actions.
• Manage the Medical Device Register for Roche IVD products and coordinate safety notifications to customers.
• Oversee translation and distribution of product documentation, CE labeling, and digital content on Roche platforms.

Required profile

• Proven knowledge of ISO 9001 quality management systems and Czech medical device/IVD regulations (SÚKL).
• Strong cross‑functional collaboration skills across HR, Sales, Logistics and Finance.
• Analytical mindset with the ability to make timely, data‑driven decisions.
• Excellent oral and written communication in Czech and English.

Required skills

• ISO 9001 documentation and audit preparation.
• Medical device regulatory expertise (SÚKL, IVDD).
• eLabDoc module management on the DiaLog platform.
• Cornerstone LMS administration.
• Translation coordination for product manuals, SDS and CE certificates.