Katalyst CRO
Overview
5 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Responsibilities
Develop regulatory strategies, review design input/output documentation, identify applicable standards and guidance documents, perform regulatory assessments to determine the impact of design/process changes, prepare regulatory submissions, maintain regulatory filings and licenses, and interact with regulatory agencies. Serve as the global regulatory liaison and primary point of contact for product and project teams for Paragon 28 software applications and surgical system hardware. Maintain expert knowledge of regulations, legislation, best practices, and guidelines related to Artificial Intelligence, Software as a Medical Device and Machine Learning (SaMD/ML). Provide regulatory guidance to product teams, develop regulatory strategies, and review and approve product design control documentation. Determine regulatory pathways and formulate regulatory strategies for the U.S. market. Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes. FDA 510(k) premarket notifications, De Novo applications, internal Letters to File, and pre-submissions, with minimal supervision. Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals. Provide risk-based guidance and regulatory input to projects and issues, ensuring cross-functional alignment and resolution. Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts. Build relationships and interface with cross-functional teams (Engineering, Manufacturing, Marketing, etc.). Build and conduct regular training in software development, software as a medical device and cybersecurity. Assess impact of changes to applicable laws and regulations and identify impact to the business and, in collaboration with other stakeholders, develop strategies to address such changes. Support responses to regulatory body inquiries and support audits by regulatory bodies. Review and understand global regulatory requirements (FDA, TGA, EU MDD, MDR, Health Canada, etc.). Provide mentoring to junior level positions. Requirements
Bachelor's degree (Engineering, Biology, or Regulatory Science) and a minimum of 3+ years related experience; or equivalent combination of education and experience. Proven experience with software as a medical device (SaMD) and mobile health app regulations. In-depth knowledge of FDA guidance on digital health, cybersecurity, and mobile medical apps. Track record of 510(k)/De Novo submissions for connected orthopedic or wearable devices. Familiarity with IEC 62304, ISO 13485, and FDA Part 11 compliance for software validation. Experience with EU MDR requirements for software and app-based devices (Annex I & XIII). Effective collaboration with software, clinical, and human factors teams. Post-market compliance expertise, including UDI, vigilance, and software change reporting. Strong understanding of cybersecurity requirements and guidance (e.g., FDA, IMDRF). Knowledge of US and/or international regulatory requirements (FDA, TGA, EU MDD, MDR, Health Canada, etc.). Direct experience with regulatory submissions for Artificial Intelligence, Software as a Medical Device and Machine Learning (SaMD/ML) products. Excellent attention to detail and proven organizational skills, with the ability to prioritize and multi-task to see projects/assignments to completion. Proficiency in Excel, Word, PowerPoint, Outlook and customer database management systems. Proven leadership and negotiation skills, ability to work with all levels, and manage cross-departmental expectations. Excellent written and verbal communication skills. Location: Pleasanton, CA
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5 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Responsibilities
Develop regulatory strategies, review design input/output documentation, identify applicable standards and guidance documents, perform regulatory assessments to determine the impact of design/process changes, prepare regulatory submissions, maintain regulatory filings and licenses, and interact with regulatory agencies. Serve as the global regulatory liaison and primary point of contact for product and project teams for Paragon 28 software applications and surgical system hardware. Maintain expert knowledge of regulations, legislation, best practices, and guidelines related to Artificial Intelligence, Software as a Medical Device and Machine Learning (SaMD/ML). Provide regulatory guidance to product teams, develop regulatory strategies, and review and approve product design control documentation. Determine regulatory pathways and formulate regulatory strategies for the U.S. market. Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes. FDA 510(k) premarket notifications, De Novo applications, internal Letters to File, and pre-submissions, with minimal supervision. Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals. Provide risk-based guidance and regulatory input to projects and issues, ensuring cross-functional alignment and resolution. Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts. Build relationships and interface with cross-functional teams (Engineering, Manufacturing, Marketing, etc.). Build and conduct regular training in software development, software as a medical device and cybersecurity. Assess impact of changes to applicable laws and regulations and identify impact to the business and, in collaboration with other stakeholders, develop strategies to address such changes. Support responses to regulatory body inquiries and support audits by regulatory bodies. Review and understand global regulatory requirements (FDA, TGA, EU MDD, MDR, Health Canada, etc.). Provide mentoring to junior level positions. Requirements
Bachelor's degree (Engineering, Biology, or Regulatory Science) and a minimum of 3+ years related experience; or equivalent combination of education and experience. Proven experience with software as a medical device (SaMD) and mobile health app regulations. In-depth knowledge of FDA guidance on digital health, cybersecurity, and mobile medical apps. Track record of 510(k)/De Novo submissions for connected orthopedic or wearable devices. Familiarity with IEC 62304, ISO 13485, and FDA Part 11 compliance for software validation. Experience with EU MDR requirements for software and app-based devices (Annex I & XIII). Effective collaboration with software, clinical, and human factors teams. Post-market compliance expertise, including UDI, vigilance, and software change reporting. Strong understanding of cybersecurity requirements and guidance (e.g., FDA, IMDRF). Knowledge of US and/or international regulatory requirements (FDA, TGA, EU MDD, MDR, Health Canada, etc.). Direct experience with regulatory submissions for Artificial Intelligence, Software as a Medical Device and Machine Learning (SaMD/ML) products. Excellent attention to detail and proven organizational skills, with the ability to prioritize and multi-task to see projects/assignments to completion. Proficiency in Excel, Word, PowerPoint, Outlook and customer database management systems. Proven leadership and negotiation skills, ability to work with all levels, and manage cross-departmental expectations. Excellent written and verbal communication skills. Location: Pleasanton, CA
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