About Belle Health
Belle Health is a women’s health company focused on developing digital medical devices to empower women to respond to their menstrual cycle-related challenges in an instant, safe, and drug-free way. Currently, we are in stealth mode, but we are preparing to launch our first medical device. The menstrual symptoms, such as pain, mood changes, and cognitive difficulties, are experienced by 80% of women throughout their menstrual, gestational, and menopausal cycles. These symptoms, including dysmenorrhea, PMDD, and PMS, have a significant impact on women’s daily lives, with 82.4% of women reporting missing work or going to work while feeling unwell due to these issues. Despite this, only a small percentage of women feel comfortable discussing these challenges with their superiors. Furthermore, 78% of those looking for solutions report that none of them are satisfying, highlighting a severe lack of research, investment and solutions in the field of women’s health. Our goal is to improve the overall health and well-being of women by providing solutions and support for their unique hormonal health challenges. By empowering women to take control of their health, we believe they can harness their unique gifts and use their experiences as a strength.
About the role
First and foremost, we’re looking for people who are excited about what we’re doing. More than a specific set of skills, we’re looking for someone that (1) has the talent/experience/drive/work ethic to drive your own work (2) understands that good employees do what you tell them to do, great employees tell you what they need to do. We’re defining a new category, so you’ll be able to use creativity to help us solve problems and delight our customers. As a Regulatory Affairs Manager at Belle Health, you will play a crucial role in developing our digital medical device and ensuring compliance with relevant regulations. Your responsibilities will include:
- Regulatory Compliance: Ensure compliance with relevant regulations, such as MDR, ISO 13485, IEC 62304, ISO 27001, and GDPR.
- Collaboration: Actively collaborate with colleagues from IT, QA, Product, Science, and Management to obtain and maintain approvals for our digital medical device.
- Risk-Benefit Analysis: Continuously conduct risk-benefit analysis and ensure all workstreams incorporate a risk management process.
- Post-Market Surveillance: Ensure processes to comply with Post-Market Surveillance requirements
- Metrics & Improvements: Establish project and process metrics to measure success and drive process improvements.
About you
- Excellent written and oral communication skills in English.
- Interest in developing your career towards a PRRC role, if not qualified yet.
- Solid experience writing clean and compact technical documentation under MDR and ISO 13485.
- Bonus points for experience with software development, ISO 27001, GDPR, and knowledge of DiGAV in Germany, and German-speaking.
Why you might be excited about us
- We are dedicated to female healthcare and aim to make a significant impact on the lives of menstruating individuals worldwide.
- Our small size means you can contribute effectively and navigate less bureaucracy. You’ll quickly take on significant responsibilities and have opportunities for rapid career advancement.
- Our team boasts a wide range of experiences and looks forward to learning from you as well.
- We’ll tailor your role to foster a career that elevates you to the next level. We deeply care about our team and are committed to growing together to achieve great things both as a team and individually.
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