Healthcare Technology Regulatory Affairs Specialist
Vor 5 Tagen
We are a dynamic and forward-thinking healthcare technology company, ONCARE GmbH, dedicated to transforming the healthcare market with our innovative platform, myoncare.
As a Quality and Regulatory Affairs Manager, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining the highest standards of quality for our products.
The ideal candidate will have at least two years of experience in Regulatory Affairs or Quality Department for medical devices, preferably in medical device software. In-depth knowledge of MDR 2017/745, EN ISO 13485:2016, CFR part 820, and relevant sections of the FD&C Act is also essential.
You will be responsible for performing gap analyses of regulatory documents and QMS documentation, deriving and implementing required adaptations in documentation and processes, and keeping regulatory documentation up-to-date.
Additionally, you will identify and execute regulatory pathways for successful market access, actively promote improvement in QMS processes, and advise other departments in daily regulatory and quality-related activities.
The salary for this position is around €80,000 - €110,000 per year, depending on your level of experience and qualifications. You will work in a central located office with plenty of lunch options and enjoy a personalized onboarding experience.
Our company offers competitive salaries with performance-based growth opportunities, global team collaboration, team events, coffee and tea stations, employee discounts, and networking opportunities with sister companies (sqanit & CONVIEN) for professional growth.
We are looking for innovators, change-makers, and minds that are ready to take on new challenges. If you are passionate about contributing to the digitalization of healthcare and shaping the future of healthcare technology, we invite you to apply today with your complete application documents, stating your earliest possible starting date and your salary expectations.
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