Regulatory Labelling Specialist

Do you bring experience with Regulatory Labelling and IFU for MDR or IVD products? Are you excited to own our labelling processes on a global basis?

Bring your knowledge and passion to SOPHiA GENETICS as our new Regulatory Labelling Specialist.

Based at our office in Rolle, Switzerland you will work closely with colleagues in RA & our lab environment.

Your Mission:

As part of our Regulatory Affairs team, you will own the Labelling and IFU processes for our IVD and MDR products on a global landscape. This role suits an individual with previous experience in Regulatory Labelling looking to gain further exposure across Regulatory Affairs.

What you’ll achieve:

• Own the processes and workflows around the creation of regulatory labelling, packaging and IFU for our MDR and IVD products.
• Drive the transition and implementation of improved systems and processes related to labelling and packaging
• Work closely with colleagues in supply chain and production on the execution of labelling processes

Requirements

• 1-3 Years experience in Regulatory Labelling, Packaging and IFU
• Ideally with exposure to MDR and IVDD/IVDR Products on an international landscape
• Comfortable building and owning projects to improve labelling systems and processes

Benefits

You will be joining an organization with the patient at the heart of every decision and action, driven by purpose as we drive exponential growth.

• A flexible and friendly working environment with a collaborative atmosphere
• International and multicultural environment
• A fast-growing company with plenty of opportunity for personal growth and development
• All the accessories you need: MacBook Pro, Keyboard, Monitor, Noise-cancelling headphones
• Excellent Medical Insurance covering Health, Dental and Vision
• Life insurance

The Process:

Apply now with your CV and any supporting information. For further information, contact our Senior Talent Acquisition Lead for Critical Hiring.

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 stakeholder from across the business.

Starting date: ASAP (or as agreed)

Location: Office (Rolle, CH)

Contract type: Permanent, Full-time