Regulatory Affairs Specialist II - Katalyst CRO : Job Details

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• Responsibilities include developing regulatory strategies, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses and interacting 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 appropriate 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.

Responsibilities

• Responsibilities include developing regulatory strategies, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses and interacting 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 appropriate 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+ year(s) 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 team.
• 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, able to prioritize and multi-task and see projects/assignments to completion.
• Proficiency in Excel, Word, PowerPoint, Outlook and customer database management systems.
• Proven leadership and negotiation skills, works well with all levels, able to successfully manage cross-departmental expectations.
• Excellent written and verbal communication skills.

Seniority level

• Seniority levelAssociate

Employment type

• Employment typeContract

Job function

• Job functionLegal
• IndustriesPharmaceutical Manufacturing

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