HYBRID WORK | REMOTE WORK | HEALTHTECH STARTUP IN BERLIN

WHO WE ARE

We are a team of serial entrepreneurs and investors who have joint forces to build and scale roclub (top funded but still in stealth mode). roclub is a Teleoperation Platform for Medical Technology disrupting the way how MedTech is operated:

• Health Organizations will be able to ensure the operation of their medical technology anywhere, anytime and for any exam.
• Medical Technicians will be able to organize their jobs more flexibly, more independently and from anywhere in the world.
• Patients will never again miss an exam or receive it late due to lack of medical technical staff and expertise.

We are building an international scalable SaaS platform with strong IoT focus.

WHAT YOU'LL DO

• You will be collaborating closely with the founders and our highly motivated and impact driven management team.
• Develop the regulatory strategy to meet business objectives and ensure global success of products.
• Responsible for the implementation, maintenance, and certifications of the company wide QM-Systems (e.g. ISO27001, ISO13485)
  
• Responsible for (medical) product registration submissions/ approvals as well as renewals and updates within the regulatory frameworks in the US and EU.
• Prepare FDA submissions and European Technical Documentation (EU MDR) for product changes and/or new product introductions.
• Maintain regulatory files and tracking databases as required and communicate with regulatory agencies as needed.

YOU'RE GOOD AT

• Approaching tasks structured and independently and with strong motivation and commitment.
• Highly analytical, structured and committed to a data-driven approach.
• Entrepreneurial mindset with the ability to find the smartest and fastest way to reach the goals.
• Extensive experience in the implementation and use of digital tools.
• People are impressed with your strong teamwork and communication skills.

YOU BRING (EXPERIENCE & QUALIFICATIONS)

• Degree in mechanical engineering, electrical engineering, biomedical engineering or related discipline.
• 5+ years of experience in medical device regulatory affairs as well as in ISO certification, 510(k) and EU MDR submission and approval process.
• Expertise with interpreting and implementing various medical device standards and global medical devices, such as electrical safety, EMC testing (e.g., IEC 62304, IEC60601 series etc.).
• Experience in project management.
• Knowledge and application of medical device QMS (e.g., ISO 13485, MDSAP etc.)
• Very good written and spoken German and English language skills complete your profile.
  

WHAT WE OFFER

• International working environment
• Flexible working time
• Remote (home)work
• Attractive remuneration including Virtual Share Option Program (VSOP)

If you are interested, we look forward to receiving your detailed application.
In case you have any questions or would like to receive further information, please contact Matthias Issing.

matthias.issing@roclub.com | www.roclub.com