Regulatory Affairs Manager
München, Remote, Anywhere
Full time
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.
How to apply
Does this sound like the right challenge for you? Leave your details on our website application form, and we will get in touch with you.
Belle Health
Belle Health is dedicated to developing precision medicine solutions for female health, beginning with premenstrual disorders. Based in Munich, we ...