SOPHiA GENETICS
Regulatory Affairs (IVDR) Manager / Sr Manager
SOPHiA GENETICS, Boston, Massachusetts, us, 02298
Regulatory Affairs (IVDR) Manager / Sr Manager
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.
Enjoy the flexibility of a hybrid work schedule allowing 2 days PW home working, collaborating closely with colleagues in either our Rolle, CH or Boston, MA corporate offices.
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 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 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 working with EU Notified Bodies / Regulatory Authorities essential; international bodies (US/Japan) beneficial.
Knowledge of oncology regulatory frameworks and companies diagnostic development highly beneficial.
As a public organisation facing ongoing commercial growth, you will bring a success‑oriented and solutions‑focused mindset that embraces team collaboration, change, growth and inclusion.
As an international organisation, English is our primary business language and you will need to bring full fluency in English.
Benefits
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. You can discuss a full breakdown with us, but as a brief overview:
US: Outstanding Medical, Dental & Vision with 90% Employer Contribution.
Company matched 401K at 4%.
Company‑paid short & long‑term disability insurance.
FSA commuter benefits.
20 Days PTO, increasing to 25 with tenure; 5 Days Sick and 14 Public Holidays.
Free EAP.
CH: Sickness and Accident coverage through Helsana.
Meal Vouchers at 90CHF PM with our partner cafeteria.
A fun and engaging work environment, with Rest & Entertainment space, full stocked free coffee machine and free fruit/snacks.
Free parking in an easy to access location.
A strong social committee whose purpose is to make SOPHiA GENETICS both enjoyable as well as rewarding.
As our global HQ, you’ll have direct interaction and exposure to senior leadership and our executive team locally.
Additional Information Starting Date: Q1 2026.
Location: Boston, MA or Rolle, CH - Hybrid work schedule.
Contract: Permanent, full time.
Schedule: 2 days PW home working.
Salary: $88,000 - $186,000 per year depending on level.
Base pay range $88,000.00/yr - $186,000.00/yr
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Enjoy the flexibility of a hybrid work schedule allowing 2 days PW home working, collaborating closely with colleagues in either our Rolle, CH or Boston, MA corporate offices.
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 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 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 working with EU Notified Bodies / Regulatory Authorities essential; international bodies (US/Japan) beneficial.
Knowledge of oncology regulatory frameworks and companies diagnostic development highly beneficial.
As a public organisation facing ongoing commercial growth, you will bring a success‑oriented and solutions‑focused mindset that embraces team collaboration, change, growth and inclusion.
As an international organisation, English is our primary business language and you will need to bring full fluency in English.
Benefits
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. You can discuss a full breakdown with us, but as a brief overview:
US: Outstanding Medical, Dental & Vision with 90% Employer Contribution.
Company matched 401K at 4%.
Company‑paid short & long‑term disability insurance.
FSA commuter benefits.
20 Days PTO, increasing to 25 with tenure; 5 Days Sick and 14 Public Holidays.
Free EAP.
CH: Sickness and Accident coverage through Helsana.
Meal Vouchers at 90CHF PM with our partner cafeteria.
A fun and engaging work environment, with Rest & Entertainment space, full stocked free coffee machine and free fruit/snacks.
Free parking in an easy to access location.
A strong social committee whose purpose is to make SOPHiA GENETICS both enjoyable as well as rewarding.
As our global HQ, you’ll have direct interaction and exposure to senior leadership and our executive team locally.
Additional Information Starting Date: Q1 2026.
Location: Boston, MA or Rolle, CH - Hybrid work schedule.
Contract: Permanent, full time.
Schedule: 2 days PW home working.
Salary: $88,000 - $186,000 per year depending on level.
Base pay range $88,000.00/yr - $186,000.00/yr
#J-18808-Ljbffr