Quality and Regulatory Specialist (Medical device technical documentation)

• Preparation of technical documentation for IVDs & FDA various risk classes.
• Post-marketing surveillance activities.
• Participating in compliance / QMS audits.
• Drafting / updating regulatory processes (procedures & records).
• Quality Management responsibilities: preparing & updating procedures, records.
• Occasionally contacting Notified Bodies.
• Preparation of PMPFs.
• Coordination of performance evaluations.
• Other, as per IVDR & FDA requirements.
• Preferable: experience with FDA.

Join a team of passionate, forward-thinking regulatory professionals dedicated to overcoming challenges and pushing the boundaries of innovation. At our company, you’ll work in an energetic environment where problem-solving is key, and every team member is driven by a shared vision of advancing medical technology. Embrace the opportunity to contribute to groundbreaking projects and make a tangible impact on the future of healthcare.

• private medical care
• remote work opportunities
• fruits
• integration events
• no dress code
• coffee / tea

Scope Fluidics S.A.