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.