Soft skills:

• Is an Excellent team player in a multicultural environment.
• Shows a “Can-do-attitude” with agility.
• Has passion for medical device.
• Self-starter with ability to work independently under pressure and react quickly to changing priorities.
• Is comfortable with decision process and decision making.

Experience & Education:

• Master’s degree in life science, engineering or related fields.
• Five (5) years minimum experience in regulatory affairs in MedTech.
• Five (3) years minimum experience in regulatory affairs Management in MedTech.
• Has proven track record in flawless registrations of medical devices in Europe and in the US. Medical device registration in APAC area is a plus Current knowledge of FDA 21 CFR part 820, Medical Device Regulation (MDR 2017 / 745), ISO 13485, ISO 14971, IEC 60601-1, IEC 62366, ISO 62364
• Strong analytical, planning and organizational skills.
• Strong interpersonal and communications skills (oral & written).
• Experience in Start-up is a strong and determinant plus.
• Fluency in English, German, or French is a plus.

Core Responsibilities

• Develops regulatory strategy for new products (Class I (s)(m)(r) and IIa) and implements plans to obtain FDA clearance/approvals, CE Mark and other foreign regulatory approvals.
• Manages compliance to all relevant regulations, rules and standards for
  products and taking part in the conformity assessment procedures with
  coordination of all concerned departments.
• Manages conformity assessment process and registration process for
  products including dossier preparation, submission to Competent Authorities or Notified Body, reviews of application and implementation.
• Accompanying development projects, issuing development-accompanying
  and technical documentation for medical devices, revising already existing
  technical documentations. Maintains regulatory compliance of Technical Files.
• Elaborates and reviews changes to existing Products, SOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.
• Communication with responsible regulatory authorities (national/international) as well as with notified bodies.
• Lead regulatory assessment of marketing claims and external communication.
• Performs staff training on the topic of regulatory affairs.

Leadership Activities 

• Foster the cooperation between diverse disciplines and functions managing a good balance between discussion, consensus, argumentation and decisiveness.
• Lead others in the completion of project tasks and sub projects.
• Smooth & facilitate the decision-making process.
• Create a work environment that supports team effectiveness.
• Provide feedback to team members.
• Assist with integration of common tools and techniques.
• Present to internal and external audiences, including board or investors.

Expertise and Problem-Solving Duties:

• Identify resource requirements, cost, and time schedules. Develop an
  implementation plan, conduct risk assessments and develop contingency
  plans to accommodate unforeseen events.
• As part of the management team, selects the specific action plans that will best meet the identified business objectives.
• Be part of the vision and translate vision to project goals, roadmap and plans.
• Analyze risks, suggest mitigation plans and develop alternatives to solutions.
• Proactively anticipate and identify risk areas, alert stakeholders appropriately.
• Able to identify and assess business risks for a given regulatory strategy.

Aspivix is a growing MedTech aiming at innovating and advancing women’s care to enable an improved gynecological practice, empowering caregivers to deliver better patients’ experience. The company is headquartered in the Lausanne region, Switzerland. Our first device, currently in development, is a new
generation of non-invasive instrument for gynecological procedures, designed to reduce pain and eliminate bleeding for millions of women every year in the world. Are you ready to join a dynamic environment and an amazing team driven by the passion to improve Women’s care for millions of women?
If so, we can’t wait for you to join our team and bring your ideas and experience to sustainably advance the Women’s care.

We offer:
• A dynamic working environment as part of a start-up.
• Working in a MedTech startup which will make a difference in women’s health and with a true mission; at ASPIVIX, we innovate women’s care because we believe that women deserve gentler and more modern methods for procedures in gynecology.
• A possibility to form your own job and to contribute developing products with bigger potential. Your imagination and willingness are the limits.
• Co-operation with a nimble multinational team of brilliant and passionate colleagues.
• A chance to influence from the early beginning the course of a growing company.

Should you want to contribute to a highly motivated and passionate team, with a lot of space for your own initiatives, send your complete application to : jobs@aspivix.com

Job description

Responsabilities

• Develop software that automates image capture, processing and data extraction from colorimetric IVDs
• Integrate the software into an app with a user-friendly graphical user interface
• Expertise in coding (essential)
• Experience in software development (preferable)
• Experience in IVD device development (preferable)
• Experience in microfluidics engineering and imaging (preferable)
• Work closely with our academic and industrial project partners to ensure the work progresses in line with the larger project objectives
• Contribute to project management, including financial and time management
• Present at internal project meetings and at international conferences
• Write peer-reviewed publications

Project background

The deMello Group (Prof. Dr. Andrew deMello) in the Institute for Chemical and Bioengineering at ETH Zürich is searching for a postdoctoral researcher to work on image capture and analysis of colorimetric in vitro diagnostic (IVD) devices. The aim is to develop software and an associated smartphone app that is able to yield a reliable and robust quantitation of the target analyte, based on data extracted from captured images. They invite candidates with research interests in software development and image analysis, with a passion for improving global health through new technologies. The position is fixed-term at 12 months in the first instance, with a possibility for extension.

They offer:

• A multicultural and multidisciplinary research environment
• Attractive hiring conditions
• Access to state of the art equipment and resources
• Strong support in career progression

ETH Zurich is one of the world’s leading universities specialising in science and technology. They are renowned for their excellent education, cutting-edge fundamental research, and direct transfer of new knowledge into society. Over 30,000 people from more than 120 countries find their university to be a place that promotes independent thinking and an environment that inspires excellence. Located in the heart of Europe, yet forging connections all over the world, they work together to develop solutions for the global challenges of today and tomorrow.

Qualifications
• You are pursuing a Masters or PhD in Physics, Electrical Engineering or a related field (you need to be registered as a student in a Swiss University to be eligible)
• You have strong fundamentals in signal and systems (analysis in both continuous and discrete domains)
• You have knowledge of frequency domain algorithms (Fourier transform, wavelets transforms, etc.)
• You have a strong mathematical foundation
• You have programming experience with either Python or MATLAB
• You have a high degree of independence, while at the same time, are able to effectively collaborate cross-team
• You have excellent communication skills and are able to convey technical concepts clearly
• Experience with radar signals and multi-antenna signals (beamforming and MIMO) is a plus
• Knowledge of analog, digital and mixed circuit design is a plus
• Machine learning algorithms (SVM, Random forest, Neural networks, etc.) is a plus

What you will do

Sleepiz is seeking an intern for a period of 6.5 months starting 1st October, 2020. This internship is an industry academic project with Innosuisse. You will participate in a project in collaboration between Swiss Federal Laboratories for Materials Science and Technology (EMPA) and Sleepiz.

You will work to develop robust algorithms for vital signs estimation. Your main focus will be to investigate strategies to estimate and characterize breathing and heart rate patterns for processing a doppler radar signal. You will work to implement, test, maintain, and document the best-performing algorithms in enterprise grade code, in close collaboration with the rest of the signal processing team members and other stakeholders.

Who are we?
Sleepiz AG (Ltd.) is a Zürich based startup with the aim to enable the medical community to take healthcare into the home environment. Sleepiz is the winner of the EIT Venture award (2019), Venture.ch in digital health (2019), DeVigier (2019), EU – H2020 Seal of Excellence (2019), Start Summit (2019), EIT award in digital health (2018), Innosuisse (2018), EU – H2020 SME Phase 1 (2018), silver winner in the Mass Challenge Switzerland (2017) Accelerator program and is ranked as the most promising digital health startup in Europe.

What Sleepiz offers
They are a dynamic, interdisciplinary, highly skilled team that is passionate about sleep. They foster a fun and energetic start-up culture in a relaxed environment. As a part of Sleepiz’s dedication to the diversity of our workforce, they offer flexible working hours together with a high degree of self-responsibility and freedom. You would have ample collaboration opportunities in a truly cross-functional team.

Salary
Total: CHF 2700 per month
(Salary: 2000 per month incl. 15% social security + 20% overhead CHF)
Sleepiz is an active proponent of gender equality in STEM. Female candidates are strongly encouraged to apply.

Your application

Do you feel like your skillsets match our needs?
Do you have what it takes to join our young and dynamic team?
Do you want to be part of the ground floor of a company that is going to take the sleep industry by storm?

Send over your CV and cover letter to career@sleepiz.com

For more information, visit their website HERE.

Who you are
(Minimum qualifications)
• You have a master’s degree in a quantitative discipline (e.g. physics, computer science, mathematics, computational biology)
• You have 4+ years industry (R&D) experience in designing, prototyping, and implementing scalable and reproducible end-to-end machine learning solutions (from research to production). Candidates with an academic background and a strong record in applying machine learning to real-world datasets are equally encouraged to apply
• You have expert knowledge of Python and are familiar with at least one deep learning framework (e.g. Tensorflow, Keras, PyTorch)
• You have a high degree of independence and an aversion to micromanagement
• You thrive in interdisciplinary environments and have excellent cross-team communication abilities. In particular, you are able to clearly convey technical concepts at a level appropriate for technical and non-technical audiences
• You are curious, inquisitive, collaborative, with a deep appreciation for diversity
• You are fluent in English (full professional proficiency)

Preferred qualifications
(In addition to the minimum qualifications above)
• You have a doctorate degree in a quantitative discipline (e.g. physics, computer science, mathematics, computational biology)
• You have a solid understanding of the foundational theory underlying machine learning (e.g. linear algebra, probability theory and numerical optimization)
• You have expert knowledge of at least one additional scripting languages (e.g. R) and of bash/shell scripting. Experience with hybrid R/Python frameworks and object-oriented programming is considered a plus
• You have demonstrated experience with building deep learning models (real-world project portfolio and/or publications)
• You have educated opinions about the designs of ML solutions, both from formal education as well as real-world experience. You are able to clearly and effectively expose such opinions and concepts to other team members and are a strong proponent of constructive dialogue
• You take pride in developing ML solutions and in documenting the data products you build together with the team
• You have experience with processing, analyzing and modeling sensor data/time series data
• You are familiar with cloud computing and development / test / production environments
• You are familiar with experimental design

EU/UK residents seeking a full-time remote position are strongly encouraged to apply. Sleepiz is an active proponent of gender equality in STEM. Female candidates are strongly encouraged to apply.

What you will do

You will work within the data science team to devise scalable and reproducible end-to-end machine learning solutions for sleep analytics. Your main focus will be research and development, combining dynamic experimentation, a passion for details and a fail-fast attitude. You will also be responsible for translating research output to production systems, in close collaboration with the software team and
other stakeholders. Finally, given your key role within the team you will have the opportunity to mentor and inspire junior data scientists/interns.

Who are we?
Sleepiz AG (Ltd.) is a Zürich based startup with the aim to enable the medical community to take healthcare into the home environment. Sleepiz is the winner of the EIT Venture award (2019), Venture.ch in digital health (2019), DeVigier (2019), EU – H2020 Seal of Excellence (2019), Start Summit (2019), EIT award in digital health (2018), Innosuisse (2018), EU – H2020 SME Phase 1 (2018), silver winner in the Mass Challenge Switzerland (2017) Accelerator program and is ranked as the most promising digital health startup in Europe.

What Sleepiz offers
Sleepiz is a dynamic, interdisciplinary, highly skilled team that is passionate about sleep. They foster a fun and energetic start-up culture in a relaxed environment. As a part of their dedication to the diversity of our workforce, thei offer flexible working hours together with a high degree of self-responsibility and freedom. Sleepiz provides performance-oriented compensation and equity ownership.

Your application

Do you feel like your skillsets match our needs?
Do you have what it takes to join our young and dynamic team?
Do you want to be part of the ground floor of a company that is going to take the sleep industry by storm?

Send over your CV and cover letter to career@sleepiz.com

For more information, visit their website HERE.