Company Description
LVIS 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.
Responsibilities:
- As a Quality Management specialist, we expect you to be knowledgeable, innovative, and committed to ensure that products we supply conform to the FDA Quality System Regulation and ISO 13485.
- Ownership of assisting leadership in implementing standard approaches to problem solving and prevention, and devising creative approaches to solving problems encountered.
- Ensuring compliance with Quality System requirements for all new product development as well as product modifications.
- Review/approve product and QMS related documents on behalf of QA.
- Partnering with cross-functional teams in verifying and validating protocols for product design and commercial releases.
- Assisting in overseeing risk management activities including hazard analysis, failure mode, effects analysis, and traceability analysis.
- Maintaining risk management documentation throughout the product lifecycle.
- Manage corrective and preventive action processes.
- Identify, plan, and participate in the implementation of process improvements.
- Support non-product software validation activities.
- Support supplier qualification and monitoring.
- Review complex complaints and complaint trends, and oversee failure investigations.
- Support development and continuous improvement of quality system procedures.
- Report to management on quality issues and trends.
- Available to be on calls in the morning or evening with global partners in their respective time zones.
- 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 communicate these changes to relevant stakeholders.
- As a subject matter expert, you will be a guide in assisting in regulatory training to team members on applicable regulations, standards, and best practices.
- You will assist the Head of Regulatory in 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 interactions with domestic and international regulatory agencies and notified bodies to address questions, providing clarifications, and successfully obtain regulatory clearance for our products.
- You will assist in establishing and maintaining 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:
- BS or MS degree in Mechanical/Electrical/Industrial Engineering or an equivalent field.
- At least 7+ years of experience working within the Quality organization of a Software Medical Device manufacturer.
- Experience in software lifecycle processes, familiar with software code review and verification methods.
- Knowledgeable in 21 CFR 820 (Quality System Regulations) and ISO 13485 is a must
- Applications of Lean principles such as Value Stream Mapping, Standard Work, 5S, Kaizen.
- Experience working with strategic suppliers.
- Experience with product lifecycle management (P/N creation, BOM creation, Document Change Control generation and management, Approved Supplier management, etc).
- Quality engineering background and experience inspections, supplier qualifications and audits.Minimum of 5+ years of experience in regulatory affairs within the medical device industry, SaMD focus is highly preferred.
- Strong knowledge of global medical device regulations, standards, and guidelines, including FDA/KFDA 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.
