Katalyst Healthcares and Life Sciences
Regulatory Affairs Specialist
Katalyst Healthcares and Life Sciences, Minneapolis, Minnesota, United States, 55400
Responsibilities:
This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA and EU regulations, ISO standards, and other regulatory agencies. Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre-submissions, 510(k)s, annual reports, and MDR CE mark submissions. Develop and implement regulatory strategies for new and modified products. ct as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions. ct as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations. Interact with regulatory agencies as part of submission review and on-site audit support. Review device labelling for compliance with global regulations; analyze and recommend appropriate changes. Support and maintain Quality initiatives in accordance with BSC Quality Policy. Participate in development and implementation of departmental policies and procedures. Foster a work environment of continuous improvement that supports BSC's Quality Policy, Quality System and the appropriate regulations for their area of responsibility. Requirements:
minimum of a bachelor's degree, preferably in a scientific or technical discipline. minimum of 2-year work experience in Regulatory Affairs or 3 years work experience in a related discipline (e.g., R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in the medical device industry. Introductory knowledge of FDA, EU and/or international regulations. Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms).
This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA and EU regulations, ISO standards, and other regulatory agencies. Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre-submissions, 510(k)s, annual reports, and MDR CE mark submissions. Develop and implement regulatory strategies for new and modified products. ct as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions. ct as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations. Interact with regulatory agencies as part of submission review and on-site audit support. Review device labelling for compliance with global regulations; analyze and recommend appropriate changes. Support and maintain Quality initiatives in accordance with BSC Quality Policy. Participate in development and implementation of departmental policies and procedures. Foster a work environment of continuous improvement that supports BSC's Quality Policy, Quality System and the appropriate regulations for their area of responsibility. Requirements:
minimum of a bachelor's degree, preferably in a scientific or technical discipline. minimum of 2-year work experience in Regulatory Affairs or 3 years work experience in a related discipline (e.g., R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in the medical device industry. Introductory knowledge of FDA, EU and/or international regulations. Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms).