– Come and innovate for a medical technology company!
We believe in a future where healthcare is more accessible. That’s why we work with specialised, self-motivated minds to develop home testing systems that combine diagnostics technology with medical knowledge and data. To support the realisation of this vision we are searching for an internationally-minded Head of Regulatory to join our growing team.
A little about your future role…
We offer a permanent position, based in Vienna, where you can grow professionally in an innovative, open, and future-oriented startup environment.
The Head of Regulatory Affairs or (Regulatory Affairs Manager or RAM) is responsible for ensuring that Bloom Diagnostics is adhering to applicable regulations and is directly reporting to the CEO
- Preparing our product for readiness to launch in US & Canada markets by compiling and co-ordinating FDA submissions and applicable regulations.
- Developing strategies for ensuring regulatory compliance
- Documenting regulatory related processes within the organisation
- Studying scientific and legal documents, including relevant technical standards
- Ensuring compliance with regulations (with a focus on medical product regulations)
- Interpreting and communicating regulations within the company
- Advising on and recommending regulatory strategies
- Directing and coordinating preparation of document packages for regulatory submissions
- Conducting or assisting on internal audits and inspections
- Communicating with regulatory agencies on administrative and routine matters
- Supporting the design control process, and assisting in the development and maintenance of regulatory files and records.
- Part of the product council and therewith responsible for input and decisions regarding regulatory product strategies
- Implementing and maintaining risk, usability & post market surveillance processes
- Moderating, supporting and consulting on risk, usability and post market surveillance process executions
- QM support in various fields including audits
- Consulting the product counsel on product strategies & decisions
- Providing training in regulatory affairs areas or activities
- Budget responsibility: as required
- Team responsibility: as required
Don’t have experience with all the points above?
Don’t worry, we are big fans of learning, training and coaching on the job. Shoot us an email and explain how we can help each other grow.
A little about us…
Bloom is an international company, with home bases in Zurich and Vienna. We are closely affiliated with venture-capitalists in Europe and overseas. Our team has proven experience in the European health tech, home-testing and medical research sectors and a proven track record of resilience in the competitive startup scene.
We value self-motivation and self-awareness, entrepreneurship, long-term thinking and collaborative teamwork. We are in the healthcare space and this requires us to constantly reflect upon how we impact the lives of our users. After all, we care for their health.
What we can offer you:
Working in a next-generation healthtech company, building and scaling a market from anew
Flexible work hours and ability to organise home-office days.
Flat-hierarchy, with an open communication style and feedback.
Team activities and outings (hiking, team retreats, etc.).
Working with an internationally diverse, young and dynamic team where English is the company language
Spacious office in 1st district Vienna (with awesome places to go for lunch and after work drinks), free coffee and tea and fruit
Yearly Vienna transit card.
Opportunity to contribute to a future where healthcare will be more prevention-focused and patient-centered
Like what you read?
To apply, send us an email at email@example.com! We are proud of our diverse and international team and are an equal opportunity employer, meaning we don’t discriminate in our hiring based on age, gender, race, or anything else.
We look forward to receiving your cover letter and CV.
Please note: When you apply with us @bloom diagnostics we will process and store the personal information that you have provided us with for the purpose of handling your application. We will store your contact details only if you instruct us to do so, otherwise your application data is deleted after 12 months. If you have any further questions regarding how we handle our data, do not hesitate to reach out to firstname.lastname@example.org.
Our salary range starts upwards from €65,000 gross per year for a full time position. Depending on what skills and experience you bring with you, this is the least we would pay.
Annotation: According to the Federal Collective Bargaining Agreement (Rahmenkollektivvertrag für Angestellte im Handwerk und Gewerbe: www.wko.at), the minimum salary class for this position is class V, depending on experience also of the successful candidate.