The ideal candidate is an expert in regulatory affairs for pharmaceuticals and/or medical devices, and is willing to develop into an all-round specialist for regulatory affairs in various industries (including animal health, cosmetics, environmental topics, …). In addition the candidate must have:

• University degree in Medicine, Pharmacy, Life Sciences, or related discipline;
• At least 5 years’ Regulatory Affairs experience in EU or US, in a regulated industry (pharmaceuticals, biologics, medical devices);
• Excellent knowledge of international regulatory standards and regulations in the areas of quality, safety, and efficacy in the EU/US/CH, other regions are a plus;
• Team player with strong interpersonal skills, excellent communicator;
• Maturity, persuasiveness, and a high level of discretion;
• Strong organizational skills with ability to multitask and independently set clear priorities;
• Excellent problem-solving “can do” capacity;
• Efficient working style and hands-on start-up mentality;
• Excellent knowledge of MS Office tools (Word, Excel, Outlook, …);
• Based in Northwestern Switzerland region;
• Excellent in written and verbal English is a must;
• Fluent in either German, French and/or Italian; other languages are an added benefit.

Tasks

HEMEX AG is committed to changing the future of healthcare by guiding the most promising European start-ups through each and every step to bring innovative pharmaceuticals, medical devices and in vitro diagnostics to the market. Headquartered close to the thriving Basel global Life Sciences hub, the goal at HEMEX is to ensure start-ups have access to a wide range of tailored products, practical solutions and fundraising support. This empowers the next generation of transformative discoveries to grow into successful and sustainable businesses, and drive change in both human and animal healthcare.

Benefits:

If you meet the described profile, we look forward to receiving your CV in English, including supporting documents, by e-mail to pascal.winnen@hemex.ch

Through your experience in the field you have the unique opportunity to bring
innovative decision support solutions to life, resolving the unmet medical
need of matching drugs with individual tumors as a prerequisite for optimal
treatment outcome in all cancer patients. You will have the meaningful and
rewarding role of supporting and guiding the therapeutic decision making of oncologists across cancer areas, and to lay the foundations for the use of our
support solutions across geographies.

If you are a pioneer, a creative problem solver with a passion for genomics,
digital health and artificial intelligence, if you are driven by an entrepreneurial
mindset, a leader by example and a team player, then you may be the right
candidate we are looking for.

Your responsibilities will include but are not limited to:
1 – Building a commercialization-ready molecular diagnostics laboratory in
Switzerland that can serve as a laboratory model across other countries (EU,
US), including all activities required to achieve accreditation, certification and
reimbursement of our services, and in compliance with the effective
international and country-specific regulations and guidelines for diagnostic
laboratories, medical devices and SaaS.
2- Supporting the building of a laboratory franchise across Europe and North
America.
3- Guiding the team’s direction, maintaining overview of planning, progress,
quality and budget.
4- Supporting the development of SCCD solutions for other cancer entities
and advancing them to commercialization readiness state, in collaboration
with our bioinformatics team and experts in the respective cancer fields
beyond-breast cancer.
5- Driving your team to make OncoGenomX a preferred diagnostics service
provider thanks to agile execution and effective partnering with oncologists,
cancer care practitioners and hospitals.
As the Head of Smart Cancer Co-Diagnostics you will be part of the
OncoGenomX leadership team, reporting to the CEO, with an option of
earning stock options and becoming a partner and/or member of the
founders group.

OncoGenomX is a Swiss venture founded in October 2019. Our mission is to
empower oncologists to choose precisely those drugs that will most
effectively help their patient to achieve durable disease control. This is made
possible by:
1- A gene expression assay to determine the biological properties,
pharmacological sensitivities and clinical behavior of individual tumors.
2- The use of artificial intelligence to determine which cancer drugs are
appropriate for every tumor and which will permanently prevent disease
progression or metastasis.
3- Provision of collective treatment results from comparable patients, who
have completed treatment informed by Smart Cancer Co-Diagnostics (SCCD).
4- A machine learning routine to continuously learn from previous treatment
decisions and therapy results.
The Head of Smart Cancer Co-Diagnostics is an exciting opportunity to set up
our Swiss Smart Cancer Co-Diagnostics Laboratory. (S)he will be responsible
for the organization and management of the laboratory, the formation of a
team and the extension of our support services to cancer types beyond
breast cancer.
At the heart of this opportunity lies the development and validation of gene
expression assays run on nCounter and Illumina instrumentation, their
validation, certification and advancement to commercialization readiness.

Contact: Wolfgang Hackl, Managing Director OncoGenomX.

E-Mail: hacklwo@oncogenomx.com

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.