SOPHiA GENETICS
Our Mission
We believe there is a smarter, more data-driven way to make decisions in healthcare and our cloud-native AI powered SOPHiA DDM Platform makes that vision a reality on a daily basis. You will have direct input to our mission to democratize data-driven medicine for the ultimate benefit of cancer and rare disease patients across the globe.
Your Mission Reporting to the Regulatory Affairs Director, you’ll be directly responsible for driving the strategy and delivering the execution on submission for our transition from IVDD to IVDR for selected products.
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 our IVDD products through to IVDR approval.
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
5+ Years Regulatory Affairs experience within Diagnostics or Medical Devices
Proven track record of successful IVDR Class B, C or D 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
Knowledge of oncology regulatory frameworks and diagnostic development highly beneficial
Benefits You will be joining an organisation with the patient at the heart of every decision and action, driven by purpose as we pursue exponential growth.
Business recognition and accolades include:
World’s most innovative companies (Top 10)
World’s smartest companies (Top 50)
100 Best Places to Work in Boston
Top 10 European Tech Startup
Top 10 European biotechs startup to watch
Top 25 East‑Coast Biotech to watch
Our benefits package is comprehensive, but varies internationally in line with local standards and laws.
Location Rolle, CH (Office Hybrid – Preferred location); Boston, MA (Office Hybrid – Secondary Location); EU5 or UK (Remote‑Hybrid; exceptionally suitable candidates)
Contract Permanent, full time
Starting Date Q1 2026
Salary MA Pay Range: $88K - $168K (Manager) / $104K - $186K (Sr Manager)
Apply Apply now with your CV and any supporting information.
#J-18808-Ljbffr
Your Mission Reporting to the Regulatory Affairs Director, you’ll be directly responsible for driving the strategy and delivering the execution on submission for our transition from IVDD to IVDR for selected products.
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 our IVDD products through to IVDR approval.
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
5+ Years Regulatory Affairs experience within Diagnostics or Medical Devices
Proven track record of successful IVDR Class B, C or D 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
Knowledge of oncology regulatory frameworks and diagnostic development highly beneficial
Benefits You will be joining an organisation with the patient at the heart of every decision and action, driven by purpose as we pursue exponential growth.
Business recognition and accolades include:
World’s most innovative companies (Top 10)
World’s smartest companies (Top 50)
100 Best Places to Work in Boston
Top 10 European Tech Startup
Top 10 European biotechs startup to watch
Top 25 East‑Coast Biotech to watch
Our benefits package is comprehensive, but varies internationally in line with local standards and laws.
Location Rolle, CH (Office Hybrid – Preferred location); Boston, MA (Office Hybrid – Secondary Location); EU5 or UK (Remote‑Hybrid; exceptionally suitable candidates)
Contract Permanent, full time
Starting Date Q1 2026
Salary MA Pay Range: $88K - $168K (Manager) / $104K - $186K (Sr Manager)
Apply Apply now with your CV and any supporting information.
#J-18808-Ljbffr