Head of Quality Assurance & Regulatory Affairs

Are you ready to lead Quality Assurance and Regulatory Affairs for cutting-edge audiology diagnostic solutions? Our WSA Diagnostic Solutions division is looking for an experienced and proactive leader to ensure compliance with global regulations and drive excellence in quality for products increasingly focused on software, firmware, and Software as a Medical Device (SaMD).Why Join Us?This is a strategic leadership role with global impact, offering the opportunity to shape compliance and quality for innovative diagnostic solutions that improve lives.Location: Burlington, CanadaWhat You’ll DoEnsure compliance with ISO 13485, FDA, Health Canada, EU MDR, and other global standards.Act as Management Representative for the QMS and ISMS, leading management reviews and audits.Oversee key QA processes: Risk Management, Document Control, CAPA, Post-Market Surveillance, and Supplier Quality.Drive QMS improvement initiatives and maintain audit readiness.Lead global regulatory activities and serve as the main point of contact for authorities.Support product development by integrating regulatory requirements into design controls and agile processes.Manage product registrations, technical documentation, and submission dossiers.Monitor regulatory changes and develop compliance strategies.Lead and develop a high-performing QA/RA team.What We’re Looking For5+ years of experience in QA/RA within the medical device industry (software experience preferred).Strong knowledge of ISO 13485, ISO 14971, IEC 62304, and global regulations (FDA, MDR, Health Canada).Proven success in design controls, V&V, and regulatory compliance for medical devices and SaMD.Certified ISO 13485 Internal Auditor is a plus.Excellent leadership, communication, and collaboration skills.Ability to work in a global, matrixed organization and influence without direct authority.Who are we?WS Audiology (WSA) is a global leader in the hearing aid industry. Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world. Our portfolio of technologies spans the full spectrum of hearing care, from distinct hearing brands and digital platforms to managed care, hearing centers and diagnostics locations.SHOEBOX Ltd is part of the WS Audiology Group (WSA). We design and develop audiometry products that are creating a seismic shift in the way hearing healthcare is provided. Utilizing iOS and web technology to replace bulky, expensive equipment, we’re bringing hearing testing into the 21st century and making it more affordable and accessible than ever before with the ambition of making a wonderful sound part of everyone’s life.Why that’s important: 5% of the world’s population suffers from disabling hearing loss, 60% of childhood hearing loss is due to preventable causes, and the majority of people with disabling hearing loss live in low-middle income countries. We can help. With our products, hearing testing can be conducted outside of a sound booth and without the need for clunky equipment (you just need a calibrated headset and an iPad), which allows for testing almost anywhere, anytime, worldwide.At SHOEBOX, your contribution will have a meaningful impact every single day. On top of that, you’ll be an integral part of an innovative team, working with the latest tools and technologies, pushing the boundaries of what the quality assurance function can do, and collaborating with teams of people who are super passionate about their crafts.In joining us, you’re joining a dedicated and passionate team that works hard and cares deeply about the change we’re making in the world. We also take time to celebrate our successes, enjoy lunchtimes together, and genuinely like and care about one another. Also, our founder knows how to do magic tricks. It’s pretty cool.To learn more about us and what we stand for, check out our story and blog.We offer competitive salaries and benefits, real work-life balance, and flexible hours. You'll be equipped with the tools you need to do your best work and you’ll be supported by a collaborative team.We invite enthusiastic and qualified applicants to submit their resume here. We thank all applicants; however only those selected for an interview will be contacted.SHOEBOX is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.