SOPHiA GENETICS · 14 hours ago
Regulatory Affairs Specialist / Manager (CDx)
Boston, MA
Full-time
Hybrid
Mid, Senior Level
$71K/yr - $168K/yr
5+ years expSOPHiA GENETICS is a company focused on driving innovative solutions in healthcare. They are seeking a Regulatory Affairs Specialist / Manager to lead regulatory strategies and submissions for their CDx and IVD portfolio, particularly with a focus on FDA and international markets.
Artificial Intelligence (AI)Big DataBioinformaticsBiotechnologyGeneticsHealth CareLife ScienceMedical
Responsibilities
Provide strategic and operational regulatory support for diagnostic and CDx products, including software-based and other complex IVD medical devices
Drive and coordinate the development and execution of US FDA and global regulatory strategies and submission plans (e.g. Q-Subs, 510(k), PMA, and equivalent pathways) to support timely product clearances and approvals
Contribute to the drafting, review, and compilation of regulatory submissions and responses, collaborating closely with clinical, quality, R&D, and commercial teams
Support interactions with regulatory authorities (e.g. FDA and other key agencies) and act as a central point of contact for CDx/IVD regulatory topics across internal stakeholders
Qualification
Required
5-8 years' Regulatory Affairs experience within Diagnostics and/or Medical Devices (complex Class II / Class III)
Practical experience contributing to FDA submissions for diagnostic and/or software medical devices (e.g. Q-Subs, 510(k), De Novo, PMA or supplements), with tangible involvement in drafting or compiling submission content
Background in diagnostics (CDx and/or broader IVD) with an understanding of NGS and/or software as a medical device highly beneficial
Experience interacting with Health Authorities (e.g. FDA) essential; exposure to additional global agencies (e.g. Health Canada, TGA, PMDA or EU Notified Bodies) highly beneficial
Familiarity with global regulatory requirements for diagnostics and an interest in expanding knowledge into new regions and evolving frameworks
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
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
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2026-01-16
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2026-01-16
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