Senior Specialist, Quality & Regulatory Affairs - - REMOTE OK
Our client, a startup company focused on developing and distributing machine learning (artificial intelligence) solutions for medical applications. The Regulatory Affairs Specialist be experienced and thoughtful about the processes necessary for achieving domestic and regulatory approval.
You'll be joining a team that delivers at high frequency by using and creating the latest technologies, interacting constantly with your team and communicating daily with the product manager. You will also be working daily with data scientists and medical doctors, who will help to integrate software solutions with the healthcare diagnosis systems, all in an environment conducive to productivity, brainstorming, and close collaboration across teams, with each team member being an integral part of the creative process.
- Coordinate all activities related to domestic and regulatory submission and approval for medical software solutions.
- Drive regulatory strategy for domestic and international markets assuring early consideration of regulatory requirements.
- Support the product development team in the implementation of regulatory requirements, including preparation and review of design and test documentation.
- Design, document, and implement product quality procedures conforming with IEC 62304, ISO 14971, 21 CFR 820, ISO 13485, and AAMI TIR45 including but not limited to:
- Risk Management (Analysis & Mitigation)
- Develop thoughtful and efficient Quality Management System and documentation (SOP, QR, WI, etc).
- Act as Training Manager to enforce and train all employees on processes and procedures in the Quality Management System.
- Own and Implement CAPA process; present CAPAs during management review meetings, and drive CAPAs to closure.
- Implement and serve as administrator to electronic document management system.
- Conduct internal audits and prepare audit reports, audit packages, and checklists.
- Mentor junior quality affairs specialists.
- Develop and execute Quality Assurance processes which enable rapid product development and product commercialization.
- Coordinate with development teams to review requirements, specifications and technical design documents to provide timely and meaningful feedback and ensure quality and regulatory compliance.
- Work closely with data science and product development teams to establish key checkpoints for product launch and subsequent version releases.
- Accurate and timely review and reporting of field quality issues; drive CAPA, nonconformances and complaints, including root cause analysis, corrective/preventative action implementation, and effective checks.
- Prepare, coordinate, and file regulatory submission documents.
- Perform regulatory assessment of product changes.
- Review and approve marketing materials to ensure compliance with advertising and promotional regulations.
- Prepare, or contribute to the preparation of post market surveillance plans and evaluate post-market data.
- Ensure regulatory requirements are met for maintenance of products.
- Support internal and external audits.
- Research and evaluate different risk factors regarding business decisions and operations.
- Stay abreast of current and novel developments in the field.
- Comply with company policies and guidelines.
- As part of a startup with a highly collaborative culture, perform other related duties and "pitch in" where needed. In the early stages, these duties will include administrative operations.
- Bachelor's degree or higher.
- Proven regulatory experience with class II or III medical devices.
- Knowledge and experience with ISO13485, 21 CFR 820, IEC 62304 and ISO 14971.
- Knowledge and experience designing and implementing a quality management system for a software company.
- Experience conducting internal audits of documentation and processes.
- Certified Quality Auditor.
- Experience with new product development standards and documentation for software products.
- Nuanced experience in regulatory submissions and technical documentation for medical devices, software and services.
- Ability to review and provide critical feedback on quality management and design documentation.
- Ability to communicate and interact with regulatory agencies and consultants.
- Excellent written and verbal skills.
Please send your resume to Denise Hamill email@example.com