Regulatory Affairs

Do you bring a background in Regulatory Affairs, and a passion for driving innovative solutions? Have you driven Reagent or Software products through IVDR approval with notified bodies?

If this sounds like you and you are driven by purpose, Join the SOPHiA GENETICS Regulatory Affairs Team as a IVDR Regulatory Affairs Manager / Senior 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 either our Rolle, CH or Bidart, FR corporate offices.

**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 Head of Regulatory Affairs you’ll be directly responsible for driving the strategy and delivering the execution on submission for our transition to IVDR.

**The value you bring**
- Provide strategic regulatory guidance for IVDR Class C and higher IVD and CDx products.
- Drive and coordinate the development and execution of regulatory strategies and submission plans to support timely product approvals and market access.
- Lead regulatory submission efforts including EU Clinical Trial Assays (CTAs), Ethical Approvals, and Notified Body filings.
- Serve as the primary point of contact for IVDR-related projects internally and externally (e.g. with Notified Bodies).

**Requirements**:
**We know that every background is different, but to be best set for success we see you bringing**:

- 8+ Years Regulatory Affairs experience within Diagnostics, Pharmaceutical or Medical Devices
- Proven track record of successful IVDR Class C or higher submissions and approval
- Direct working knowledge of either IVDR submission for software-based devices or NGS-based diagnostics (ideally both). EN/IEC 62304 Beneficial.
- Experience of working is EU Notified Bodies / Regulatory Authorities essential, international bodies (US/Japan) Beneficial.
- Knowledge of oncology regulatory frameworks and companies diagnostic development highly beneficial

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.

**Benefits**

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:
CH
- Sickness and Accident coverage through Helsana
- Meal Vouchers at 90CHF PM with our partner cafeteria
- A fun and engaging work environment, with Rest & Entertainment space, full stocked free coffee machine and free fruit/snacks
- Free parking in an easy to access location
- A strong social committee whose purpose is to make SOPHiA GENETICs both enjoyable as well as rewarding
- As our global HQ, you’ll have direct interaction and exposure to senior leadership and our executive team locally

FR
- Forfait-Jour working types
- Health benefits for you and your family covered by 80% employer contributions
- Life Insurance and pensions contribution
- SWILE meal vouchers and home office allowances

**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**

‘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?’
- We appreciate the value external partners can bring, but we operate a direc