At CEyoo, we enthusiastically embrace the challenges of the medical technology industry. Our goal is to minimize the regulatory burden for our clients while ensuring the safety and quality of medical devices and IVDs. As a Legal Manufacturer and European Authorized Representative, we play a crucial role as a partner to companies developing innovative and life-saving medical devices and IVDs.CEyoo is a young company with the strength of a big sister . As part of the Metecon Group, boasting over 60 Regulatory Compliance Experts, we offer you a dynamic environment for your professional growth. We invite you to share our vision of regulatory excellence in the medical technology sector - Welcome aboard!Explore our current job openings and become a part of an extraordinary team!
We are currently looking for a:
Quality Specialist / Person Responsible for Regulatory Compliance (PRRC) (m/f/d)
PDF, 141 kB
Your Responsibilities:
- Ensuring regulatory compliance for our customers' medical devices.
- Creation, review, approval, and monitoring of technical documentation and up-to-date EU Declaration of Conformity.
- Post-Market Surveillance (PMS) monitoring of customer products in accordance with regulations.
- Creating, reviewing, approving, and monitoring Quality Management (QM) processes and their interfaces with relevant stakeholders.
- Meeting reporting obligations as per applicable regulations (MDR/IVDR).
- Evaluating incidents and complying with reporting requirements.
- Acting as an intermediary between regulatory authorities and our customers by communicating with Notified Bodies.
- Handling deviation reports from audits and defining actions in cooperation with relevant authorities.
You're a Good Fit for Us if You:
- Have a minimum of 5 years of professional experience in regulatory affairs or quality management systems related to medical devices.
- Ideally have already taken on the responsibilities of a PRRC.
- Value independent work and autonomous communication with our partners, customers, and authorities, especially in the execution of our services.
- Hold a degree in a natural science, medical, or technical field.
- Possess excellent knowledge of quality management (EN ISO 13485) and the applicable regulations for medical devices (MDR) and IVD (IVDR).
- Are passionate about medical devices/IVD and want to enrich a team of great colleagues.
- Have very good proficiency in both German and English.
Why Are We the Right Fit for You?
- We thrive on flat hierarchies.
- We offer you a job with a purpose: Everything we do revolves around the safety of medical devices and IVDs for users and patients.
- Teamwork makes the dream work: Open communication, mutual support, and a culture of respect are not just catchphrases for us; they're the way we operate.
- Freedom & Self-Responsibility: We provide a modern work environment and benefits like flexible scheduling, remote work options, 30 days of vacation, disability insurance, and employee participation in the company after one year of employment.
- We take time for your onboarding and don't lose sight of you – you're not just a number to us; you matter. The numbers prove it: we invest 2% of our annual revenue in the professional and personal development of our employees.
- We offer you a secure work environment with great people and exciting challenges.
Let's start a conversation! Send us your application at bewerbung@ceyoo.de.
Apply Now and Become Part of Our Team!
We warmly invite you to send your application via email to bewerbung@ceyoo.de. If you have any questions about the advertised position or our company, our HR Manager, Wiebke Hermanns, is available to address all your inquiries.We look forward to getting to know you soon!Would you like a PDF version of the job posting?
You can easily download it here.
Unleash Your Potential: Grow with Us!
We value initiative and personal responsibility, fostering flat hierarchies to enable swift decision-making. However, this is not at the expense of your personal and professional development—quite the opposite in fact.Our aim is to support you in all aspects—personally, professionally, and financially. We'd be happy to discuss the details in your first conversation with us, where we'll introduce our career paths and demonstrate how we can assist your progress.To ensure a smooth start with us, you'll be paired with an experienced colleague as a buddy in the beginning. They will accompany you during your first weeks, ease your transition, and help you quickly adapt to our company culture. If you later express interest in having a mentor to further advance your professional and personal development, we also offer opportunities for that. We believe that the exchange between seasoned and new team members enriches everyone involved and contributes to collective growth.Are you ready for this exciting journey? We look forward to getting to know you and working together on your success!
Your Journey into the Team Begins Now!
Assuming we both agree that we're the right fit for each other, what happens next? We'll continue to stay in touch until your first day of work, as we discuss the details for your successful start and gather some documents and information from you.We've crafted a well-thought-out plan for your onboarding, so your initial days with us will be quite eventful: You'll have the opportunity to meet all team members, participate in essential introductions, set up your home workspace with a computer and accessories, be introduced to our work tools and methods, and, of course, receive specialized training from your team.Our colleagues are always here to support you and answer any questions you may have.We look forward to welcoming you!
Begin Your Career with Us - Apply Today!
We look forward to receiving your application! Please send your documents to bewerbung@ceyoo.de.If you have any questions about the advertised position or our company, don't hesitate to contact our HR Manager, Wiebke Hermanns, at +49 621 123469-044 or bewerbung@ceyoo.de. She is available at any time to provide information.We're eager to get to know you!Interested in a PDF version of the job posting? You can download it here.