SOPHiA GENETICS · 3 days ago
Regulatory Affairs (IVDR) Manager / Sr Manager
Boston, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$88K/yr - $186K/yr
8+ years expSOPHiA GENETICS is a leader in data-driven medicine, focused on improving outcomes for cancer and rare disease patients. They are seeking an IVDR Regulatory Affairs Manager/Senior Manager to drive regulatory strategy and submissions for their IVDR transition, ensuring timely product approvals and market access.
Artificial Intelligence (AI)Big DataBioinformaticsBiotechnologyGeneticsHealth CareLife ScienceMedical
Responsibilities
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)
Qualification
Required
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 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
Full fluency in English
Benefits
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 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
Company
SOPHiA GENETICS
SOPHiA GENETICS is a biotechnology firm that aims to support healthcare professionals by maximizing the power of data-driven medicine.
201-500 employees
H1B Sponsorship
SOPHiA GENETICS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (2)
2022 (4)
2021 (5)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$265.15MKey Investors
Perceptive AdvisorsaMoon FundGeneration Investment Management
2024-05-02Post Ipo Debt· $15M
2021-07-23IPO
2020-10-01Series F· $110M
Leadership Team
Jurgi Camblong
Founder and CEO
George Cardoza
Chief Financial Officer
Recent News
2025-12-24
2025-12-12
Company data provided by crunchbase