Director, Regulatory Affairs

Summary

Join the SOPHiA GENETICS Regulatory Team as Director, Regulatory Affairs and contribute to improving cancer and rare disease patient outcomes globally. This role, ideally based near the Boston Fenway office but with remote US Northeast options, involves strategic regulatory guidance for companion diagnostics collaborations. You will drive regulatory designations, manage submissions for premarket approvals, and represent SOPHiA GENETICS in regulatory meetings. The position requires extensive experience in regulatory affairs within the pharmaceutical or diagnostics industry, specifically with IVD regulatory submissions. SOPHiA GENETICS offers a comprehensive benefits package including medical, dental, vision, life insurance, 401k matching, paid time off, and more.

Requirements

• 10+ years of Regulatory Affairs experience in the pharmaceutical or diagnostics industry, including 5+ years in IVD
• Proven track record of successful diagnostics regulatory submissions (e.g., PMAs, 510(k)s, IDEs, CTAs)
• Direct working knowledge of CDx, CTA and Associated BioPharma programms is critical - (Ideally this will include NGS Diagnostics, but may include wider Dx including PCR.)
• Comprehensive knowledge of drug and diagnostic development processes, with the ability to interpret and apply regulatory guidance flexibly and strategically
• A commercialised, risk-aware approach to drive development and partnerships forward
• 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

Responsibilities

• Provide strategic regulatory guidance for CDx collaborations with BioPharma partners, and work closely with the BioPharma business team on strategic initiatives related to regulatory approvals and market access
• Drive efforts to secure regulatory designations and contribute to CDx strategy development and submissions
• Oversee and manage submissions for premarket approvals (PMAs), CTAs, IDEs, and other global regulatory filings
• Represent SOPHiA GENETICS in regulatory meetings, including pre-submission meetings, advisory committees, and consultations with global health authorities
• Provide regulatory intelligence, informed of evolving global regulatory landscapes, including changes in guidance related to IVD products, NGS, CDx, SaMD, and precision medicine

Preferred Qualifications

Knowledge of Oncology regulatory frameworks highly valuable

Benefits

• Outstanding Medical (with Telemedicine), Dental, and Vision Plan with 90% employer contributions, including $0 deductible plans options
• Life and AD&D company provided
• Company 4% match 401K contributions
• Company-paid Short and long-term disability insurance
• 20 Days PTO (Increases with tenure), 5 sick days and 13 Public holidays recognised
• FSA commuter benefits
• Supplemental employee insurance options are available for Accident, Critical Illness, Hospital and Legal
• Voluntary Pet Insurance and Auto and Home options
• Employer Assistance Program free for all employees