Regulatory Affairs Manager
1 month ago
Job type: Full-time
Hiring from: Germany Only
Category: Finance / Legal
Cara Care aims to support every person in the world with a gastrointestinal disease with the first therapeutic digital companion for digestive care. Our platform combines the power of UX, UI, Data Science, Marketing, Tech, Medicine, Business, and Psychology to shape the user experience and provide the first evidence-based, digital therapy for digestive health. To date, Cara Care has helped more than 650,000 people across Germany and the United States manage digestive diseases with over a 78% success rate.
How it works:
By downloading the Cara Care app, individuals can customize their experience by keeping a digital food and symptom log to track personal data. It will then analyze the data and show correlations to make improvements in your everyday diet. If you choose to purchase the premium upgrade, you will gain access to personalized nutrition therapy. The premium upgrade gives you full access to our licensed Dieticians, Customer Care team and a 12 week program that is specifically tailored to you depending on your illness and symptoms. Our therapy programs also include mental health interventions with hypnotherapy and gut-directed relax sessions. The digital platform allows users to get effective and personalized treatment outside of the doctor’s office.
GI diseases are highly influenced by factors like diet, stress, physical activity, and mental health. Cara Care can help identify a person’s triggers for symptoms and flare ups, and then tailor the professional treatment to reduce those symptoms and enhance their quality of life. By monitoring your digestive health, you can improve your overall well-being and feel better by making smarter choices for your body.
According to the Massachusetts Medical Society, gastrointestinal diseases cost $136 billion annually in healthcare expenditures, more than heart disease and trauma in annual costs. Tens of millions of individuals deal with gut issues, and there is a huge gap between those who seek GI help and those who suffer. Digital therapeutics is a part of the next wave in healthcare, and mobile software can have a significant therapeutic effect on patients. According to the U.S. National Library of Medicine, point-of-care tools such as applications on smartphones have been shown to support better clinical decision-making and improved patient outcomes. Offering a mobile product gives users a more convenient and comfortable way of tackling their health issues.
As our Regulatory Affairs Manager you’ll take ownership of all things regulatory at Cara Care in a very critical role to the company’s future and help fulfil relevant national and international regulatory requirements. This role will report directly to the Chief Operating Officer.
What it is like to work with us:
We are an interdisciplinary team of doctors, designers and software engineers who are all passionate about what we are building and how it can help people. Our work is inspired by our patient’s journey and our actions are focused on impact and results. We thrive in a dynamic, fast-paced work environment, while appreciating what it means to be healthy and well.
To learn a bit more about our motivation, our team and company, you can visit our career page: https://cara.care/careers
- Develop and execute company’s global regulatory strategy working closely with senior management team
- Lead our medical software certification process and oversee the continuous compliance for medical software in EU (MDD, MDR) and US (FDA).
- Keep abreast of legislative developments in the countries or regions in which the company distributes its products or services
- Gather, structure, and formalize relevant information in order to fulfill requirements
- Create, implement, and document processes together with internal cross-functional teams like Engineering, Product, Quality management, R&D
- Perform periodic internal and external audits on company procedures and processes
- Build relationships and align with external stakeholders such as the notified body as person responsible for regulatory compliance according to MDR Article 15
- Relevant work experience in regulatory affairs for medical devices, preferably in stand-alone software as a device and knowledge of all applicable standards in EU and USA
- Experience with Quality Management Systems compliant with the ISO 13485, ideally also compliant with 21 CFR part 820
- Ability to own regulatory processes working closely with software development, clinical and business teams
- Work in a reliable, precise, and solution-oriented way
- Excellent communication skills both written and spoken in English and German
- A high independence and hands-on mentality.
Ideally you also have:
- A university degree in a relevant area such as law, medicine, pharmacy, engineering or another scientific discipline
- Ability to adapt and thrive in a fast-paced, start-up environment, ability to iterate on existing set-ups and concepts.
- A demonstrated ability to work under uncertain conditions and go-to-market of new products
- The ability to deliver results in a fast-paced, metric-driven environment and high tolerance for ambiguity
- Meaningful work – help people improve their lives
- A vibrant team and a friendly working atmosphere
- Ability to significantly influence the direction of our startup
- Competitive salary with regularly salary reviews
- Participate from our success: Equity options
- 26 days holiday a year (plus public holidays)
- The best equipment and setup to be productive
- Flexible working hours. If you prefer early starts, late finishes or remote work
- Monthly team events
- A well-equipped office in the heart of Berlin with plenty of snacks, drinks, fresh fruit and a great espresso machine
1) Application Review
We will review your application as quickly as possible and reply to you with the next steps. If we have not selected your CV/LinkedIn profile, please do not let that put you off applying again. We get many applications and sometimes it is just not the right match. We try our best, but often cannot provide you with individual feedback if we get a lot of applications.
2) Introductory Call with HR
If we move on to the next stage, we will arrange a brief intro call where we can tell you more about us and chat through what you are looking for. We are also open to answer your questions about Cara Care. (Tip: It is best to make calls in a quiet place, so please pick a time where you know you are going to be free.)
3) Phone Interview with Hiring Manager
If you wish to proceed in the hiring process with us, we will schedule an interview call with the hiring manager to discuss your previous work experience and your career aspirations. We may sometimes also send you a case study to complement the skill assessment.
4) On-Site Interviews with Our Team & Offer
Following an interactive interview, you will meet the team in person. If we both think that it is a good fit, we will make you an offer. We value your time and try to make the process as fast as possible and will always provide you with feedback from all of our interview stages.
At Cara Care we care about equal opportunities
Diversity is important to us. We need a team with all kinds of different perspectives, experiences and backgrounds. That's why we're committed to hiring people regardless of race, religion, colour, national origin, sex, sexual orientation, gender identity, age or disability.
We understand that applying for a new job takes a lot of work and we really value your time. Our team is looking forward to reading your application!
Before you apply, please check if any restrictions apply in terms of time zone or country.
This job has a geo-restriction in place: Germany Only.
Please mention that you come from Remotive when applying for this job.
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