Katalyst CRO
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Regulatory Affairs Specialist II
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Katalyst CRO 1 day ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Specialist II
role at
Katalyst CRO 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 level
Associate Employment type
Employment type
Contract Job function
Job function
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Regulatory Affairs Specialist II
role at
Katalyst CRO 1 day ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Specialist II
role at
Katalyst CRO 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 level
Associate Employment type
Employment type
Contract Job function
Job function
Legal Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Specialist jobs in
Alameda, CA . Union City, CA $100,000.00-$120,000.00 1 week ago Medical Devices Regulatory Affairs Strategy Specialist
San Francisco, CA $118,000.00-$172,000.00 6 days ago Regulatory Compliance Specialist / Req 822408492
Alameda, CA $83,241.60-$124,862.40 1 day ago San Francisco, CA $86,500.00-$105,000.00 1 month ago Quality Assurance & Regulatory Affairs Manager
Regulatory Affairs Compliance Specialist - Pleasanton, CA
Pleasanton, CA $115,000.00-$125,000.00 1 day ago Union City, CA $100,000.00-$120,000.00 1 week ago Senior Regulatory Affairs Specialist - Lingo (on-site)
Principal Regulatory Affairs Specialist US New Product Introduction Diabetes Care (on-site)
Alameda, CA $98,000.00-$196,000.00 8 months ago Regulatory Affairs Manager Heart Failure (on-site)
Pleasanton, CA $112,000.00-$224,000.00 1 week ago Associate Director of Regulatory Affairs
Senior Regulatory Affairs Manager APAC - Diabetes Care
Regulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site)
Regulatory Operations Specialist - Temporary
Alameda, CA $86,700.00-$173,300.00 1 week ago South San Francisco, CA $148,000.00-$162,000.00 22 hours ago Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
Alameda, CA $112,000.00-$224,000.00 3 weeks ago Regulatory Affairs Manager APAC - Diabetes Care (on-site)
Associate Director Regulatory Affairs APAC - Diabetes Care
Alameda, CA $146,700.00-$293,300.00 5 months ago San Francisco, CA $103,000.00-$139,000.00 3 weeks ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr