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Regulatory Affairs Specialist / Manager (CDx)

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SOPHiA GENETICS

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Location:
United States , Boston

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Category:
IT - Software Development

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Contract Type:
Employment contract

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Salary:

71000.00 - 168000.00 USD / Year
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Job Description:

Join the SOPHiA GENETICS Global Regulatory Affairs Team as a Regulatory Affairs Specialist / Manager, and enable us to make a positive impact on the outcomes for cancer and rare disease patients worldwide. 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 Global Regulatory Affairs Director, you will be directly responsible for driving and executing regulatory strategies and submissions for our CDx and IVD portfolio, with a particular focus on FDA and key international markets.

Job Responsibility:

  • 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
  • Success-orientated and solutions-focused mindset that embraces team collaborations, change, growth and inclusion
  • Full fluency in English

Nice to have:

  • Background in diagnostics (CDx and/or broader IVD) with an understanding of NGS and/or software as a medical device
  • Exposure to additional global agencies (e.g. Health Canada, TGA, PMDA or EU Notified Bodies)
What we offer:
  • 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

Additional Information:

Job Posted:
March 24, 2026

Work Type:
Hybrid work
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