Software as a Medical Device Implementation and Certification Lead
F. Hoffmann-La Roche Ltd
Basel Headquarter,Basel-City,Switzerland,
vor 7 Tg.

Who We Are

At Roche, over 90,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-

focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche's Pharma Research and Early Development Informatics team is the bridge between digital technology and science. We help drive medical innovation and are integral to the realisation of truly Personalised Healthcare and the development of innovative treatments for our patients.

Digital tools, such as smartphones or wearables, can now continually measure and collect vital health information or Digital Biomarkers from patients in a convenient way.

Digital Biomarkers are changing how future medicines will be developed and could lead to more personalised use of new medications that will transform the lives of patients.

Advances in wearable devices, such as phones, watches, textiles or delivery devices, which track a patient’s vital signs and monitor for symptoms, all have the potential to vastly accelerate clinical development.

We’re seeking future-thinking innovators who know how to apply their expertise to help transform the practice of medicine.

The Position

Here are what some of your tasks and responsibilities will be :

  • Bridge clinical development solutions into marketable medical device products
  • Establish processes and lead the technical development, testing and release of CSV and Software as a Medical Device (SaMD) mobile solutions according to applicable SOPs and regulatory standards
  • Manage deployment and lifecycle maintenance of SaMD mobile solutions in the operational phase i.e. driving implementation of software bug fixes and improvements in cooperation with development, test and installation teams, and change management of validated solutions
  • Drive the team’s compliance work with Quality and Regulatory Affairs to ensure that mobile SaMD solutions adhere to the applicable medical device and pharmaceutical regulations
  • Prepare and deliver high profile management presentations on project progress
  • Drive engaging interactions with internal and external organizations to help advance the adoption of the developed solutions
  • Who You Are

    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies.

    Where a job title is not considered the final definition of who you are, but the starting point. If you bring the following qualifications, we are looking forward to your application :

  • very good university degree (MSc. level or above) in neuroscience, medical or natural science, computer science, business informatics, or similar
  • 6 years' of experience with medical devices for disease management, including testing and lifecycle management
  • track record in developing and bringing digital health platforms (ideally SaMD) to market, including verification / validation, evidence development for clinical utility, and regulatory clearance / approval
  • excellent quality mindset and attention to detail
  • substantial experience with the fast lifecycle of mobile applications development and / or deployment
  • real passion for digital innovation in healthcare, and especially for using novel technologies to modernize disease / treatment management
  • track record of managing large project teams in very complex, agile and competing environments
  • used to drive your work independently, plan work ahead and manage and direct execution by others
  • excellent communication skills
  • native-English speaker or equivalent, written and spoken
  • Should you have experience in the pharmaceutical or diagnostic industry, ideally with hands-on involvement in clinical device development or have previous clinical experience in Multiple Sclerosis, Parkinson’s Disease or Huntington’s Disease, you are the ideal team member we are searching for.

    If you are proud of contributing and feel you have the dedication to teamwork and innovation that we are seeking, then Roche is the organization for you.

    Every role at Roche plays a part in making a difference to patients’ lives. If you want work in a passionate team, make your mark & improve lives, apply now.

    Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills.

    The more inclusive we are, the better our work will be.

    We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

    If you have questions, please check our FAQs and videos on / faq.

    Helpful links illustrating recent work in our Digital Biomarker Programme team :

    Digital Biomarker programme overview :

    Parkinson’s Disease : Huntington’s Disease :

    Huntington’s Disease : Multiple Sclerosis :

    Multiple Sclerosis :

  • At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-
  • focused healthcare groups. Our success is built on innovation, curiosity and diversity.

    Roche is an equal opportunity employer.

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