Natus is hiring a Regulatory Affairs Specialist for a 9-month hybrid role in Oakville, Ontario. Focus on managing regulatory submissions and enhancing compliance for neuro solutions. This position is ideal for those beginning their career in regulatory affairs.
You'll be actively involved in preparing documentation for submissions and renewals while monitoring compliance with international regulations. This role fosters collaboration and growth within a patient-centric culture, helping you gain hands-on experience in a meaningful field. Key Responsibilities:
Manage compliance for international regulatory submissions
Interpret EU MDR 2017/745 and global regulations
Develop and update quality procedures and documentation
Collaborate across regulatory teams for consistency
Maintain Technical Files and support audits Requirements:
Bachelor’s degree in a related discipline
Minimum 1 year of relevant experience in regulatory affairs
Solid knowledge of ISO 13485 and other frameworks
Technical writing skills and meticulous attention to detail
RAC certification is advantageous Contribute to regulatory initiatives at Natus while developing your qualified skills in a supportive setting.