Sr. Reg Affairs Specialist in Intellectt Inc

Job Title: Sr. Reg Affairs Specialist Location: Remote Duration: Long TermJob DescriptionFacilitate regulatory submissions for CGM devices, ensuring compliance with relevant regulations and standards.Stay updated with changes in regulatory requirements pertaining to CGM devices and provide guidance to internal stakeholders.Collaborate with cross-functional teams to ensure timely approval and market clearance for new products or modifications.Lead regulatory activities for CPAP devices used in the treatment of sleep apnea, including submission preparation and interaction with regulatory agencies.Monitor and interpret regulatory developments impacting CPAP devices, advising on necessary actions to maintain compliance.Coordinate with manufacturing and quality teams to ensure regulatory requirements are met throughout the product lifecycle.Manage regulatory submissions and approvals for oxygen concentrators, ensuring alignment with applicable regulations and standards.Conduct regulatory assessments for new product developments or changes to existing products, addressing any compliance issues.Provide regulatory support during audits and inspections, including documentation review and response to regulatory inquiries.Oversee regulatory activities related to electric wheelchairs, including product registrations and notifications.Develop and maintain regulatory strategies for electric wheelchair products, considering global market requirements.Collaborate with R&D and engineering teams to assess regulatory impact and ensure compliance with design and manufacturing standards.QualificationsBachelor's degree in a relevant field (e.g., biomedical engineering, regulatory affairs).Minimum of 4+ years of experience in regulatory affairs for medical devices, with a focus on the mentioned product categories.Proficiency in interpreting and applying regulations such as FDA, EU MDR, and ISO standards.Strong project management skills with the ability to prioritize and manage multiple tasks effectively.Excellent communication and interpersonal skills, with the ability to collaborate across functions and influence decision-making. Show more Show less Должностной уровень Специалист Тип занятости Полный рабочий день Должностные обязанности Информационные технологии Отрасли Кадровое обеспечение и подбор персонала