Senior Regulatory Specialist
4 weeks ago
Mozarc Medical is a pioneering company in the field of holistic kidney health technology. Founded in 2023 by DaVita and Medtronic, we offer a unique start-up experience backed by the support of two industry leaders. Our mission is to reimagine the future of kidney health technology, and we put our patients at the center of all we do.
Job Title: Senior Regulatory SpecialistWe are seeking a highly skilled Senior Regulatory Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and executing global regulatory strategies for new and existing medical devices. Your expertise will ensure compliance with FDA, EU MDR, and other global regulatory requirements.
Responsibilities:- Develop and execute global regulatory strategies for new and existing medical devices
- Assess product and process changes, serving as regulatory point of contact on large-scale projects
- Manage devices and kits, ensuring product complies with all global regulations
- Assist in the review of product labeling, ensuring compliance with materials of concern and international standards
- Review and approve advertising and promotional materials to ensure regulatory compliance
- Collaborate with cross-functional teams, including R&D, Quality, and Marketing, to provide regulatory guidance and support throughout the product lifecycle
- Interact with regulatory authorities and notified bodies
- Assist in the development and maintenance of internal regulatory policies and procedures
- Bachelor's degree and minimum of 4 years relevant experience or advanced degree and 2 years of experience
- In-depth knowledge of FDA, EU MDR, and other global regulatory requirements for medical devices
- Proven experience with regulatory submissions and technical files
- Mastery with Excel; and experience using Smartsheets
- Notary Public
- Prior history with Windchill, is a plus
At Mozarc Medical, we offer a comprehensive total rewards package and opportunities to grow, develop, and give back to the communities where we live and work. We provide a rewarding work environment that values our employees and empowers them to reach their full potential.
Physical Job Requirements:The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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