Regulatory Affairs Director

vor 2 Wochen

Rolle, Schweiz SOPHiA GENETICS Vollzeit

Would you like to be part of a dynamic and exciting team delivering high level support that has a direct impact on the lives of cancer and rare disease patients worldwide? Do you want to own the regulatory lifecycle of SOPHiA GENETICS product as we pioneer within healthcare?

Bring your knowledge and passion to SOPHiA GENETICS as our new **Regulatory Affairs Director**.

**Your Mission**:
Reporting to the VP, Quality & Regulatory, you will lead our global RA Team enabling us to drive forward with new and existing products within the global regulatory landscape. You will own and develop the strategies to ensure pre-market and post-market regulatory compliance.

**What you’ll achieve**:

- Develop, implement and execute regulatory strategies for selected projects and lead project management for product registration/submission for diagnostic and RUO, in international markets (EMEA, NORAM, APAC and LATAM).
- Drive and position SOPHiA GENETICS as a leading influencer on new and upcoming regulations within IVD, MDR and most importantly Software as a Medical Device
- To ensure that products and processes comply with the legislation of the markets where they are or wanted to be distributed by monitoring and assessing worldwide registrations, trends and hot topics that may impact the company across all portfolios and by implementing regulatory changes to maintain registrations and compliance (ISO 13485:2016, IVDD, MDR, IVDR, 21 CFR 809, etc.).
- Lead our global RA Team

**Requirements**:
**Your background**:

- Previous management/leadership experience within the regulatory affairs function of an IVD Diagnostics company is essential. Further exposure to software as a medical device or similar diagnostics software is valuable. Regulatory affairs experience exclusively within pharma products is unsuitable.
- Working knowledge of global regulatory requirements including EU IVDD, IVDR, MDR and ISO 13485/14971. Knowledge of FDA QSR/ 21CFR Part 820 is advantageous.
- BSc, MSc or PhD within a relevant field (Biology, Genomics, Biotechnology or wider life sciences)
- As we pioneer within new and innovative spaces, an entrepreneurial and commercial business-first mindset will see you best set for success.

**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.

The Process:
Starting date: ASAP as agreed

Location: Office-Hybrid (3 Days PW) - Rolle

Contract type: Permanent, Full-time

  • Regulatory Affairs Associate

    vor 3 Wochen

    Rolle, Schweiz SOPHiA GENETICS Vollzeit

    **_We believe there is a smarter, more data-driven way to make decisions in health_**. **As we pass 1,000,000 genomic profiles analyzed and look to the future of our platform, we are now searching for a Project Manager who will be help in transitioning our platform to the next level Our mission is to bring data analytics solutions to market, to support...

  • Animal Nutrition R&d Director

    vor 2 Wochen

    Rolle, Schweiz Archer Daniels Midland Company Vollzeit

    Rolle Switzerland Research & Development **Animal Nutrition R&D Director** Location : Rolle, Switzerland **Position Overview**: The Animal Nutrition (AN) R&D Director is a senior leadership role responsible for guiding regional R&D teams across Europe. Reporting directly to the AN R&D Vice President, the R&D Director ensures that regional teams align with...

  • Design Assurance Specialist

    vor 2 Wochen

    Rolle, Schweiz SOPHiA GENETICS Vollzeit

    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...

  • Director, Global Systems Engineering

    vor 3 Wochen

    Rolle, Schweiz Honeywell Vollzeit

    The Director of Systems Engineering will build and lead a team which has primary ownership of the entire system architecture for each offering. This team leads and coordinates interdisciplinary engineering activities and deliverables for complex programs. They create and manage system engineering designs to support interface management; system performance,...

  • Legal Intern

    vor 3 Wochen

    Rolle, Schweiz Archer Daniels Midland Company Vollzeit

    Rolle Switzerland Legal, Compliance, Regulatory Affairs, Corporate Security At ADM, we unlock the power of nature to provide access to nutrition worldwide. With industry-advancing innovations, a complete portfolio of ingredients and solutions to meet any taste, and a commitment to sustainability, we give customers an edge in solving the nutritional...

  • Design Assurance Specialist, Rolle

    vor 2 Wochen

    Rolle, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with: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...

  • Design Assurance Specialist

    vor 2 Wochen

    Rolle, Schweiz Sophia Genetics SA Vollzeit

    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...

  • Design Assurance Specialist

    vor 2 Wochen

    Rolle, Schweiz SOPHiA GENETICS Vollzeit

    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...

  • Design Assurance Specialist

    vor 2 Wochen

    Rolle, Schweiz Sophiagenetics Vollzeit

    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...

  • Design Assurance Specialist

    vor 1 Stunde

    Rolle, Schweiz Sophiagenetics Vollzeit

    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...

  • Quality Associate

    vor 3 Wochen

    Rolle, Schweiz SOPHiA GENETICS Vollzeit

    We believe there is a smarter, more data-driven way to make decisions in health_. As we pass 1,000,000 genomic profiles analyzed and look to the future of our platform, we are now searching for a Quality Intern who will be be part of a dynamic and exciting international team. Our SaaS DATA Platform combines deep expertise in life sciences and medical...