At Clinomic, we rethink the hospital.
Not only are we creating breakthrough products for our customers, we are shaping the healthcare sector's movement toward smart, efficient and resource-driven digital transformation. With a patient-centric view, we combine cutting-edge research with advanced technologies to ensure optimal treatment for every patient.
We create solutions, not products. Solutions that have a lasting impact on the lives of our patients, the working reality of our users and the well-being of our society. Among other prestigious awards, we were named one of the TOP 50 startups in Germany 2021.
Clinomic Medical GmbH, a subsidiary of Clinomic Group, is a dynamic, fast-growing MedTech company focused on developing innovative technology in intensive care medicine.
The Opportunity
As a Quality and Regulatory Affairs Manager, you will play an essential role and experience working in a fast-paced and dynamic environment. Your focus will be on the RA part but also include QM topics
- Creation, checking and maintaining the technical documentation of our products for international submissions
- Active participation in audits and inspections
- Coordination, implementation, and maintenance of international product approvals
- Communication with authorities, internal specialist departments, external service providers and international customers
- Implementation and continuous improvement of the established processes and promoting our quality culture at Clinomic
About you
- Completed technical or scientific degree or a comparable qualification
- Several years of professional experience in a similar position
- Experience with FDA submissions and inspections
- In-depth knowledge of the regulatory requirements of medical devices, (e.g., ISO 13485, ISO 14971, 21 CFR part 820, MDR)
- Experience in Risk Management for medical devices
- A high level of teamwork and communication skills
- Excellent writing, oral presentation and communication skills in English
Bonus points, if
- You have a background in software as medical device
- You are fluent in German
- You have knowledge in Cybersecurity
- You have knowledge in IT Security and Data Protection
What we offer in addition
- No micromanagement! You work independently using an agile approach in the team and as a part of a rapidly growing medtech company
- Competitive salary, commensurate with experience.
- Support in personal development and reaching your career goals in a flat hierarchy surrounding
- 30 vacation days
- Free membership in Urban Sports Club
- Home office flexibility
- Company pension scheme / betriebliche Altersvorsorge with a 50% company match
- A multicultural, engaged and cool team
- Positive working environment based on trust, empowerment and inclusion
At Clinomic, we know that diversity inspires innovation and creativity, and we welcome people from all backgrounds and experiences.
Sounds great?
Please send us your CV with your start date and salary expectations.