Quality & Regulatory Affairs Manager
Have you worked with software medical devices or medical devices that have a software element? Do you have experience from quality management, MDD/MDR and FDA approval processes? Do you want to advance your career in the direction of regulatory affairs? You may be just the person we are looking for!
Neuro Event Labs is a growing medtech company. Our service combines computer vision and machine learning to provide neurologists with data to make the right treatment decisions. Our mission is to help epilepsy patients and their doctors through technology. We believe that everyone deserves a good life, and we believe that our product will contribute to better results in the treatment of epilepsy patients.
Our product provides a revolutionary tool for neurologists and nurses to treat epilepsy patients more efficiently than before. We currently operate across Northern and Central Europe and the UK with further expansion to US / North America.
We are looking for a Quality and Regulatory Affairs Manager to join our team in Finland.
Key Responsibility Areas:
- Planning, managing, organizing and scheduling our quality management operations.
- Verifying that all company and regulatory policies and procedures have been documented, implemented and communicated.
- Ensuring that our processes and policies meet applicable regulatory guidelines which include but are not limited to ISO 13485, US FDA 21 CFR and EU MDR.
- Advising our science team throughout the clinical evidence generation process.
- Staying well-informed about existing regulations as well as regulatory evolutions and developments.
- Filing appropriate compliance reports with regulatory authorities.
- Identifying compliance issues that require follow-up.
- Planning and implementing efficient and effective utilization of our resources, including the utilization of external consultants.
- Acting as the Management Representative in our Management Team.
- Ideally providing quality and regulatory guidance in at least one technical area: release management, requirements specification, or software development in a Linux-based product
- Challenging tasks to be solved in a highly regulated medical environment.
- Meaningful work every minute of the day.
- A caring team that believes in transparency and honest feedback.
- Shared enthusiasm about a state of the art, innovative product.
- Plenty of opportunities to learn.
Neuro Event Labs is a multinational company and daily communication is mainly done in English. Fluent written and spoken English is required.
This is a full-time position. We offer a competitive salary and other benefits. We value expertise, enthusiasm, and true commitment above all; the rest is negotiable.
If you have any questions, please contact us at email@example.com.
To apply, send an application and your CV to firstname.lastname@example.org. We’d love to hear more about who you are and why this position is your next job!
By applying, I confirm that I have read and accepted the Privacy Notice.