What are the responsibilities and job description for the Regulatory Affairs Specialist position at Health Wealth Safe?
The Regulatory Affairs Manager is responsible for developing and implementing documentation policies to ensure compliance with US and international regulations for cardiovascular devices.
They prepare and follow up on regulatory submissions such as FDA 510(k), CE Technical Documentation, and Canadian Device Applications, serving as the liaison with regulatory agencies.
The role includes reviewing product changes, engineering change orders, labeling, and promotional materials to maintain regulatory compliance, and providing regulatory support to product development teams.
The manager reviews regulations, mentors junior staff, and may negotiate submission issues with authorities.
Qualifications include a bachelor’s degree, at least 5 years of medical device regulatory experience, experience authoring regulatory documents, and familiarity with standards like ISO.
Proficiency in English and understanding of scientific/technical aspects of medical devices are required.
They prepare and follow up on regulatory submissions such as FDA 510(k), CE Technical Documentation, and Canadian Device Applications, serving as the liaison with regulatory agencies.
The role includes reviewing product changes, engineering change orders, labeling, and promotional materials to maintain regulatory compliance, and providing regulatory support to product development teams.
The manager reviews regulations, mentors junior staff, and may negotiate submission issues with authorities.
Qualifications include a bachelor’s degree, at least 5 years of medical device regulatory experience, experience authoring regulatory documents, and familiarity with standards like ISO.
Proficiency in English and understanding of scientific/technical aspects of medical devices are required.