Head of Regulatory Affairs
Head of Regulatory AffairsCompany DescriptionLVIS Corporation is on a mission to revolutionize the entire continuum of neurological care by developing AI driven software tools to help physicians accelerate patient throughput and improve patient diagnostic and treatment outcomes.
We have an international team with our headquarters located in Palo Alto, California, USA, and we have an office in Gangnam, Seoul, South Korea.
We are looking for talented individuals to join us in our mission to transform the neurology health care industry.
Job DescriptionThe Head of Regulatory Affairs will play a pivotal role in scoping in short term and long term regulatory strategy while ensuring compliance with international regulatory requirements, standards, and guidelines for our software products.
You will collaborate closely with cross-functional teams, including Data Science, Quality, and Clinical Research to support product development from a regulatory perspective.
Your expertise and leadership will be critical in navigating the complex regulatory landscape and securing domestic regulatory and international approvals for our innovative products.
Responsibilities Developing and Implementing Regulatory Strategies Defining and executing short term and long term regulatory strategies in supporting the development, approval, and commercialization of our neuroscience products compliant with our Quality Management System.
Staying abreast of evolving domestic and international regulations, guidelines, and standards across the medical device industry, particularly for those relevant to SaMD and pharmaceuticals.
Providing guidance and recommendations to cross-functional teams regarding regulatory requirements, pathways, and potential risks You will also monitor the changes in regulatory requirements and communicating these changes to relevant stakeholders As the subject matter expert, you are the guide in assisting in regulatory training to team members on applicable regulations, standards, and best practices Regulatory Submissions and Approvals You will lead the preparation and submission of regulatory documentation, including 510(k) submissions, Letter to File strategies, clinical trial applications, usability testing, and post-market regulatory filings Collaborating with internal stakeholders to ensure timely and accurate preparation of regulatory dossiers, technical files, and other relative documentation Leading the interactions with domestic and international regulatory agencies and notified bodies to address questions, providing clarifications, and successfully obtain regulatory clearance for our products Compliance and Risk Management The establishment and maintenance of procedures and systems for regulatory compliance, including internal SOPs, documentation control, and post-market surveillance Conducting regulatory assessments to identify and mitigate potential compliance risks Support internal and external audits, as well as regulatory inspections by maintaining proper documentation while maintaining responsiveness to additional inquiries Minimum Requirements Bachelor's degree in a scientific or technical discipline (advanced degree preferred) Minimum of 10
years of experience in regulatory affairs within the medical device industry, SaMD focus highly preferred with pharmaceutical experience is beneficial Strong knowledge of global medical device regulations, standards, and guidelines, including FDA regulations e.
g.
(21 CFR), ISO 13485, and other relevant requirements Proven experience in preparing and submitting regulatory filings (510(k), etc.
), and interacting with regulatory agencies Excellent understanding of risk management and quality management systems (ISO 13485, ISO 14971) Ability to interpret complex technical and scientific information and translate it into regulatory strategies and documentation Strong project management skills with the ability to prioritize and manage multiple projects simultaneously Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams and external stakeholders Regulatory certifications (RAC, CQA) are a plus Recommended Skills Assessments Clinical Research Clinical Trials Communication Data Science External Audits Estimated Salary: $20 to $28 per hour based on qualifications.
We have an international team with our headquarters located in Palo Alto, California, USA, and we have an office in Gangnam, Seoul, South Korea.
We are looking for talented individuals to join us in our mission to transform the neurology health care industry.
Job DescriptionThe Head of Regulatory Affairs will play a pivotal role in scoping in short term and long term regulatory strategy while ensuring compliance with international regulatory requirements, standards, and guidelines for our software products.
You will collaborate closely with cross-functional teams, including Data Science, Quality, and Clinical Research to support product development from a regulatory perspective.
Your expertise and leadership will be critical in navigating the complex regulatory landscape and securing domestic regulatory and international approvals for our innovative products.
Responsibilities Developing and Implementing Regulatory Strategies Defining and executing short term and long term regulatory strategies in supporting the development, approval, and commercialization of our neuroscience products compliant with our Quality Management System.
Staying abreast of evolving domestic and international regulations, guidelines, and standards across the medical device industry, particularly for those relevant to SaMD and pharmaceuticals.
Providing guidance and recommendations to cross-functional teams regarding regulatory requirements, pathways, and potential risks You will also monitor the changes in regulatory requirements and communicating these changes to relevant stakeholders As the subject matter expert, you are the guide in assisting in regulatory training to team members on applicable regulations, standards, and best practices Regulatory Submissions and Approvals You will lead the preparation and submission of regulatory documentation, including 510(k) submissions, Letter to File strategies, clinical trial applications, usability testing, and post-market regulatory filings Collaborating with internal stakeholders to ensure timely and accurate preparation of regulatory dossiers, technical files, and other relative documentation Leading the interactions with domestic and international regulatory agencies and notified bodies to address questions, providing clarifications, and successfully obtain regulatory clearance for our products Compliance and Risk Management The establishment and maintenance of procedures and systems for regulatory compliance, including internal SOPs, documentation control, and post-market surveillance Conducting regulatory assessments to identify and mitigate potential compliance risks Support internal and external audits, as well as regulatory inspections by maintaining proper documentation while maintaining responsiveness to additional inquiries Minimum Requirements Bachelor's degree in a scientific or technical discipline (advanced degree preferred) Minimum of 10
years of experience in regulatory affairs within the medical device industry, SaMD focus highly preferred with pharmaceutical experience is beneficial Strong knowledge of global medical device regulations, standards, and guidelines, including FDA regulations e.
g.
(21 CFR), ISO 13485, and other relevant requirements Proven experience in preparing and submitting regulatory filings (510(k), etc.
), and interacting with regulatory agencies Excellent understanding of risk management and quality management systems (ISO 13485, ISO 14971) Ability to interpret complex technical and scientific information and translate it into regulatory strategies and documentation Strong project management skills with the ability to prioritize and manage multiple projects simultaneously Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams and external stakeholders Regulatory certifications (RAC, CQA) are a plus Recommended Skills Assessments Clinical Research Clinical Trials Communication Data Science External Audits Estimated Salary: $20 to $28 per hour based on qualifications.
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