Regulatory Affairs Specialist: 12-month Contract

Natus Medical Incorporated is a company that has been delivering industry-leading neuro solutions for over 80 years. They are currently seeking a Regulatory Affairs Specialist for a 12-month contract position to manage international regulatory submissions and ensure ongoing compliance across global markets. Responsibilities Manage international regulatory submissions and registration processes, including regions such as LATAM (e.g., Brazil ANVISA), APAC (e.g., Japan PMDA, China NMPA), and EMEA markets Interpret and apply regulatory requirements, with a focus on EU MDR 2017/745 and global standards Develop, update, and maintain internal quality procedures and product-specific documentation Collaborate with global Regulatory Affairs teams to ensure consistency and compliance Prepare and maintain Technical Files and Design Dossiers for CE Marking and regulatory submissions Monitor project progress and report on MDR compliance milestones Support audits from Notified Bodies, Competent Authorities, and other regulatory agencies Skills Bachelor's degree in Regulatory Affairs, Quality, Life Sciences, Engineering, or a related field Minimum of 1 year of relevant experience in medical device regulatory affairs Strong knowledge of medical device regulations: ISO 13485, MDD, MDR, and other international frameworks Technical writing skills and attention to detail Ability to work methodically and drive continuous improvement English language fluency required Regulatory Affairs Certification (RAC) is a plus Benefits Company bonus or commission plan Company Overview Natus Medical Incorporated (Natus) offers medical equipment, software, supplies and services for the diagnosis, monitoring, and treatment of impairments and disorders effecting the brain, neural pathways, and eight sensory nervous systems. It was founded in 1987, and is headquartered in Auckland, Auckland, NZL, with a workforce of 1001-5000 employees. Its website is