Design Assurance Specialist

Do you bring working knowledge of design assurance within IVD across the US & Europe? Are you passionate about being at the forefront of innovation and enabling growth?

If this sounds like you and you are driven by purpose, Join the SOPHiA GENETICS Regulatory Team as a Design Assurance Specialist, and enable us to make a positive impact on the outcomes for cancer and rare disease patients worldwide.

Connected to our corporate office in Rolle, this role has a hybrid work schedule and you should expect to spend 3 days on site collaborating with colleagues and stakeholders.

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 Senior Director, Regulatory Affairs you will be responsible for managing the design assurance and quality process for NGS products, and work cross-functionally to ensure compliance with international regulatory standards

The value you bring

• Oversee the execution of Design Control processes, including development and maintenance of Design History Files (DHFs), Design Control Plans (DCPs), Risk Management Files (RMFs), and other essential documentation to meet regulatory standards (FDA 21 CFR 820, ISO 13485, ISO 14971)

• Work cross-functionally and foster a collaborative environment to provide guidance and support on technical issues around verification, validation and design whilst identifying process optimization and areas for continuous improvement

• Take a commercially focused, risk-aware approach to risk management, identifying risking through the development lifecycle and building appropriate mitigation plans

Requirements

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

• 3-6 years within Regulatory/Quality, with at minimum of 2 years in Design Assurance of NGS or IVD technologies
• In-depth working knowledge of FDA regulations (21 CFR 802), ISO 13485, ISO 14971, with expertise in design control and regulatory submissions (510k, CE marking)
• Comfortable working cross-functionally, with stakeholder up to & including C-Suite with a commercialised, risk aware mindset.
• Degree educated within biomedical Engineering or simialr life sciences with additional certificates (i.e. Certified RAC) advantageous.

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 will be rejected at application stage.

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:

• Sickness and Accident coverage through Helsana
• Meal Vouchers at 90CHF PM with our partner cafeteria
• Free coffee, fruit and snacks
• As part of our flagship corporate office, you'll have in-person access to our strong agenda of social activities, in-perosn townhalls, kick-off and mid-year events

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:

‘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: ASAP 

Location: Rolle, CH (Hybrid, 3 Days PW)

Contract: Permanent