Junior Regulatory Affairs and Quality Specialist

We’re on a mission to bring AI to cardiac diagnostic and treatment. Working at Cardiomatics means empowering hundreds of physicians across Europe to provide better diagnosis and treatment for thousands of patients. Our goal is to implement machine learning techniques to improve cardiac diagnostics.
We are a team passionate about digital health and new technology, and together we have created a dynamic, supportive environment where we can grow each day.

Job description

Responsibilities:

• Support ensuring compliance of a product with the Medical Device Regulation (MDR) 2017/745.
• Prepare regulatory and quality processes within the company.
• Update and help to maintain the technical documentation.
• Monitor, analyze and evaluate quality indicators, audits results, feedbacks and risk management activities.
• Implement appropriate corrective and preventive actions as well as improvements in the quality system.
• Communicate with Notified Body, Competent Authorities and Authorised Representatives.
• Collaborate with cross-functional teams to ensure regulatory compliance and high product quality throughout the software development life cycle.
• Help conduct internal audits and organize external audits and inspections.
• Register a device in new markets and ensure ongoing compliance in existing markets.

Requirements

• Advanced (C1) verbal and written English language skills.
• University degree (final-year students are welcome).
• Eager to learn how to interpret standards and regulatory provisions.
• Eager to work with documentation and technical files.
• Analytical capabilities, problem solving skills, attention to detail and ability to operate independently.
• Thrive for self development and willingness to take on new challenges.

Nice to have:

• Experience in regulatory affairs within the medical device industry or related.
• Knowledge of ISO 13485 or ISO 9001.
• Knowledge of Medical Device Directive or Medical Device Regulation (MDR 2017/745).
• Knowledge of FDA Current Good Manufacturing Practice (CGMP) regulation.
• Knowledge of quality management systems and software development processes, especially related to medical devices.

We offer:

• Work in a professional, collaborative and supportive environment.
• Gaining experience with the regulatory and quality aspects of revolutionary technologies (AI, cloud software, SaaS).
• Lots of interesting challenges that will develop you professionally.
• Flexible working hours, ability to use our office or remote work.
• Startup culture environment, great atmosphere for open minded people.
• Training budget.
• Attractive compensation package with bonus component.
• Employee Stock Options Plan.