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 each month.

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

We are looking for a proactive Regulatory and  Quality (RA/QA) Manager to join our team and shape the regulatory and quality landscape of our class IIa medical device (SaaS platform using AI to conduct ECG analysis).

Responsibilities

• Manage and take responsibility for all regulatory and quality aspects of a class IIa Software as a Medical Device (SaMD).
• Ensure compliance of a product with the Medical Device Regulation (MDR) 2017/745.
• Shape and control the regulatory and quality processes within the company. 
• Update and maintain technical documentation.
• Register a device in new markets and ensure ongoing compliance in existing markets.
• Take ownership of the Quality Management System in accordance with ISO 13485.
• Act as the Quality Representative.
• Communicate with Notified Body, Competent Authorities and Authorised Representatives.
• Act as the primary advisor to the product team on regulatory and quality matters.
• Collaborate with cross-functional teams to ensure regulatory compliance and high product quality throughout the software development life cycle.
• Prepare, implement, and maintain quality assurance policies and procedures.
• Conduct internal audits, organize and support external audits.

Requirements

• Excellent knowledge of English (C1).
• Knowledge of Medical Device Regulation (MDR 2017/745).
• Experience in regulatory affairs within the medical device industry or related.
• Ability to interpret and understand standards and regulatory provisions.
• Eagerness to take ownership and responsibility for regulatory compliance and quality management. 
• Strong proactive attitude and attention to details. 
• Thrive for self development and willingness to take on new challenges.

Nice to have:

• Knowledge of ISO 13485, ISO 14971, IEC 62304, and IEC 82304
• Familiarity with the software development life cycle and experience working with software.
• Experienced in third party audits and inspections.
• Knowledge of FDA Current Good Manufacturing Practice (CGMP) regulation.

We offer:

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