Description:

As the VP of Quality & Regulatory Affairs, you will own regulatory and quality compliance strategy and execution for Cardiosense. You will drive the company’s overall regulatory strategy, guide the build-out and implementation of our quality system, develop regulatory submissions, and lead discussions with regulatory/government agencies. This role will involve determining regulatory requirements for novel products that do not have clear precedent and offer opportunities to engage in thought leadership around regulation of AI in medicine. This role with involve both hands-on work as an individual contributor and the opportunity to build out Cardiosense’s regulatory and quality team.

Responsibilities:

• Plan and lead interactions with the FDA and other regulatory agencies
• Prepare regulatory submissions
• Drive regulatory strategy and determine regulatory submission requirements in collaboration with product development, clinical affairs, clinical advisors, and regulatory consultants
• Oversee our quality management system, including drafting and updating quality & regulatory policies, processes, and procedures
• Maintain up-to-date knowledge of changes and updates to global standards/regulations and provide interpretations across cross-functional teams
• Guide response to audits from regulatory agencies and notified bodies
• Collaborate with company leadership to prepare resourcing plans, establish training practices, and lead hiring within Regulatory and Quality Affairs team
• Map agile software development processes to meet applicable FDA and ISO quality standards
• Conduct internal audits to ensure compliance with company policies
• Participate and engage in thought leadership working groups around the regulation of AI in clinical practice

Qualifications:

• Bachelor’s degree in Engineering, Medicine, Science or a related field is required, advanced degree preferred
• 8+ years of experience in Regulatory Affairs within the medical device industry
• Positive, can-do attitude that is supportive of others and effective within a dynamic, entrepreneurial environment
• Ability to be a self-starter and be productive under ambiguity
• Extensive experience developing successful 510(k), De Novo, and CE Mark submissions for medical technology products
• Experience translating software development processes to relevant FDA and ISO standards while preserving agile development cycles
• Hands-on experience and thorough understanding of global quality and regulatory requirements for medical devices, including FDA CFR Part 820, ISO 13845, IEC 62304, AAMI TIR45, ISO 14971, and/or EU MDR
• Understanding of HIPAA, patient privacy, and cybersecurity considerations strongly preferred
• Experience with software as a medical device (SaMD) and clinical decision support (CDS) products highly preferred, knowledge of basic machine learning and artificial intelligence concepts is a plus but not required
• Startup experience preferred

Location and Travel:

• Candidates located in or willing to relocate to the Chicago, IL area are preferred, however a remote location with be considered for this role.
• This position may require 10-20% travel depending on candidate’s location.

Cardiosense is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, religion, disability status, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.