Katalyst CRO
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
Act 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
Act 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 labeling 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
A minimum of a bachelor's degree, preferably in a scientific or technical discipline.
A 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).
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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
Act 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
Act 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 labeling 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
A minimum of a bachelor's degree, preferably in a scientific or technical discipline.
A 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).
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