Senior Specialist Regulatory Affairs, Medical Devices, CathVision / 1855

The Company
Welcome to CathVision, a pioneering medical device company at the forefront of transforming cardiac care.  Founded in 2013, they are revolutionising the field of cardiology and empowering cardiologists to redefine treatment of cardiac arrythmias. Their ECGenius™ System acquires high-fidelity, low-noise cardiac electrograms that allow cardiologists to diagnose and treat complex atrial arrhythmias with unprecedented precision, including challenging conditions like atrial fibrillation (AF).  The ECGenius™ System received FDA clearance in 2022, followed by the CARDIALYTICS™ AI Suite, which was FDA cleared in August 2023, becoming the first and only FDA cleared EP recording system with AI algorithm to measure success of cardiac ablation. CathVisions journey of innovation and ambition is now further fuelled by a new round of funding where they have secured $9 million to accelerate global adoption of their ECGenius™ System. The team and cultureA diverse, passionate, and uniquely skilled team of 35 individuals (and growing!) distributed across Europe and the US, with brand new headquarters in the vibrant neighbourhood of NordVest, in central Copenhagen.  They are an international company with the added benefit of spousing Scandinavian business values – a flat structure, a short line of command, and flexible working conditions. They practiced hybrid working before it was even “a thing”.  Collaboration, self-management, and continuous learning – these are not just buzzwords. CathVision’s values are the foundation of how they work and will be necessary behaviours for you to succeed in the role. They share respect for each other and are good at solving challenging tasks. They value being open, professional, trustworthy, and honest. If you're driven by innovation, pushing boundaries, and committed to making a tangible, positive impact in society, they invite you to be a part of their team.

 

             Senior Specialist Regulatory Affairs, Medical Devices

• Improving treatment & lives of those suffering from cardiac arrhythmia
• You will be working with regulatory strategies for active medical devices
• You have influence and work with a diversity of new products and projects
• Fluency in Danish is not a prerequisite for this role.

 

The Challenge
The QA/RA team is responsible for developing the regulatory strategy, preparing submission, and maintaining the licences to operate for the new products. This is a great opportunity to join a growing team working in a fast pace and multidisciplinary environment.

You bring expertise of regulatory affairs for active Medical Devices, as well as an ability to contribute towards regulatory strategy and development projects. You are a skilled Project Leader, a good Stakeholder Manager that feels comfortable with cross functional projects.

You will work and collaborate closely with the software, data science, and system engineering teams in all phases of product development, from idea inception through to design, V&V, submission, and interaction with the FDA & NB.

Your main responsibilities cover:

• Drive or participate in the development of regulatory strategies
• Supporting development and lifecycle projects
• Maintain a deep understanding of new and existing regulatory requirements
• Reviewing technical file documentation
• Assemble regulatory submission package and support submission process.
• Interact with regulatory authorities to ensure regulatory clearance
• Assist the company during certification audits and inspections
• Maintaining the regulatory processes within the Quality Management System

Their working language is English, why you need excellent written and verbal communication skills in English. Fluency in Danish is not a prerequisite for this role. You will report to the Director of Quality Assurance and Regulatory Affairs.

Your Talent
The ideal candidate has a technical background, i.e., a degree in Engineering or Life Science. They expect you to have 5 years of experience in a regulatory position within the medical device industry (active medical devices, software, or IVD). The right candidate has good understanding of the Quality Management Systems requirements according to ISO 13485, MDR, and CFR 21 CFR 820. Experience in CE and 510(k) submissions compilation together with a consultant is a plus. Excellent knowledge of MS Office is required.

You have shown high quality standards and commitment to meet deadlines. You have a pragmatic and holistic approach toward regulatory interpretation and implementation. You are self-driven, have a proactive and positive mindset, good decision-making skills and you can deal with ambiguity. You are used to work in an international environment with a fast-paced and diverse workday. You integrate well into a team as well as working independently on an assignment.

Application
Best Talent is responsible for the recruitment for this position at CathVision and reviews your application on a confidential basis. Forward your application including your CV attention “1855/ Senior RA” by way of e-mail to job@besttalent.dk  You can read more about Best Talent at www.besttalent.dk.