IVDR Expert; Regulatory Affairs

Do you bring a track record of successfully driving NGS Reagents or Diagnostic Software through IVDR submission to approval, including with notified bodies? Do you have a passion for driving innovative solutions within a regulatory framework?

If this sounds like you and you are driven by purpose, Join the SOPHiA GENETICS as an IVDR Expert for our Regulatory Affairs team as Regulatory Affairs Specialist, Manager or 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. Suitably qualified candidates may be considering remote/hybrid in EU5 or UK.

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.

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.

• 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).

• 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 working with EU Notified Bodies / Regulatory Authorities essential
• Knowledge of oncology regulatory frameworks and diagnostic development highly beneficial

As a public organisation facing ongoing commercial growth, you will bring a success-orientated and solutions-focused mindset that embraces team collaborations, change, growth and inclusion.

As an international organisation, English is our primary business language and you will need to bring full fluency in English. As part of your recruitment journey, you should expect to meet English-only speakers, so for best chances of success, you should include your CV in English. Non-English CVs have a high likelihood of being rejected at application stage.

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. You can discuss a full breakdown with us, but as a brief overview:

• 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

• Sickness and Accident coverage through Helsana
• Meal Vouchers at 90
  
  CHF 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…