Regulatory Affairs Specialist / Manager, CDx
SOPHiA GENETICS
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • United States
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Salary
💰 $71,000 - $143,000 per year
About the role
- 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.
Requirements
- 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
- Must be fluent 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory AffairsFDA submissionsQ-Subs510(k)PMADe Novodrafting regulatory submissionscompiling submission contentdiagnosticssoftware as a medical device
Soft Skills
collaborationcommunicationstrategic thinkingoperational supportinterpersonal skillscoordinationproblem-solvingattention to detailadaptabilityfluency in English