Regulatory Affairs (IVDR) Manager/Sr Manager

Regulatory Affairs (IVDR) Manager/Sr Manager

SOPHiA GENETICS

Rolle, Switzerland or Bidart, France

Do you bring a background in Regulatory Affairs, and a passion for driving innovative solutions? Have you driven Reagent or Software products through IVDR approval with notified bodies?

If this sounds like you and you are driven by purpose, Join the SOPHiA GENETICS Regulatory Affairs Team as a IVDR Regulatory Affairs Manager/Senior Manager, and enable us to make a positive impact on the outcomes for cancer and rare disease patients worldwide.

Your mission

Reporting to the Head of Regulatory Affairs you’ll be directly responsible for driving the strategy and delivering the execution on submission for our transition to IVDR.

The value you bring

• Provide strategic regulatory guidance for IVDR Class C and higher IVD and CDx products.
• Drive and coordinate the development and execution of regulatory strategies and submission plans to support timely product approvals and market access.
• Lead regulatory submission efforts including EU Clinical Trial Assays (CTAs), Ethical Approvals, and Notified Body filings.
• Serve as the primary point of contact for IVDR-related projects internally and externally (e.g. with Notified Bodies).

Requirements

We know that every background is different, but to be best set for success we see you bringing:

• 8+ Years Regulatory Affairs experience within Diagnostics, Pharmaceutical or Medical Devices.
• Proven track record of successful IVDR Class C or higher submissions and approval.
• Direct working knowledge of either IVDR submission for software-based devices or NGS-based diagnostics (ideally both). EN/IEC 62304 Beneficial.
• Experience of working is EU Notified Bodies/Regulatory Authorities essential, international bodies (US/Japan) Beneficial.
• Knowledge of oncology regulatory frameworks and companies diagnostic development highly beneficial

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