Job Description
Do you bring a background in Regulatory Affairs, and a passion for driving innovative solutions? Have you contributed to FDA or global regulatory submissions for complex CDx, IVDs or software-based medical diagnostic devices?
If this sounds like you and you are driven by purpose, 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.
Enjoy the flexibility of a hybrid work schedule allowing 2 days PW home working, collaborating closely with colleagues in our Boston, MA corporate office.
Our mission
We believe there is a smarter, more data-driven way to make decisions in healthcare and our cloud-native AI powered SOPHiA DDM Platform makes that vision a reality on a daily basis. 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.
Your mission
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.
The value you bring
- 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.
We know that every background is different, but to be best set for success we see you bringing:
- 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
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.
As an international organisation, English is our primary business language and you will need to bring full fluency in English. As part of your recruitment journey, you should expect to meet English-only speakers, so for best chances of success, you should include your CV in English. Non-English CVs have a high likelihood of being rejected at application stage.
You will be joining an organisation with the patient at the heart of every decision and action, driven by purpose as we pursue exponential growth.
Business recognition and accolades include:
- World’s most innovative companies (Top 10)
- World’s smartest companies (Top 50)
- 100 Best Places to Work in Boston
- Top 10 European Tech Startup
- Top 10 European biotechs startup to watch
- Top 25 East-Coast Biotech to watch
Our benefits package is comprehensive, but varies internationally in-line with local standards and laws. You can discuss a full breakdown with us, but as a brief overview:
US:
- 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
Our DNA
Like the strands of DNA itself, SOPHiA GENETICS and the team are deeply interconnected and reliant on each other to deliver. There are common threads across the team. Things that bind us together. Those things are Relentless Curious; Resilient & Nimble and Fearlessly Adventurous
Our Virtues
At SOPHiA GENETICS we established our 7 Virtues to clarify how our principles show up each day through action. We Decide; We Do; We Collaborate; We Innovate; We Empower; We Adapt and We Learn.
At the centre of our Virtues is our Mantra, We Care, which provides a constant reminder of the compassionate, benevolent, and hopeful nature of our mission and how it should be threaded through each of our Virtues and everything we do. Learn more about our DNA and Virtues on our Careers portal
The Process
We use the power of AI to help our partners make decisions. If you’re utilising AI in your search and application process, why not use some of these prompts, or read our AI guide.
‘What impact can I expect to have on the world by working at SOPHiA GENETICS?’
‘I have an interview with SOPHiA GENETICS. What should I know before I meet with them?’
‘I am a *job title* - What can SOPHiA GENETICS offer my career?’
Apply now with your CV and any supporting information.
Suitably qualified candidates will be invited through an interview and screening process where you will speak with members of our Talent Acquisition Team, the hiring leader alongside key colleagues and stakeholders from across the business. If you need additional support for accessibility, please contact our TA team for assistance.
We appreciate the value external partners can bring, but we operate a direct-hiring model and we are not looking to utilise agency support at this time. All hiring is controlled by Talent Acquisition, potential partners should liaise through TA and not our hiring teams please.
Starting Date: Q1 2026
Location: Boston, MA - Hybrid work schedule
Contract: Permanent, full time
MA Pay Range: $71K -$143K (Specialist) / $88K - $168K (Manager)
Disclaimer: The estimated pay range represents a good faith estimate of what the Company expects to pay a successful applicant for the listed position and applies specifically to candidates based in Massachusetts. Due to various factors, the estimated pay range may vary in other locations. Should the level or location of the role change during the hiring process, the applicable base range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, job related skills, years of experience, location, relevant education or training, internal equity, and alignment with market data. The range does not include benefits, and if applicable, bonus, commission, or equity.
