Paige is a software company helping pathologists and clinicians make faster, more informed diagnostic and treatment decisions for patients with cancer by leveraging decades of data from the world’s experts in cancer care. We are leading a digital transformation in pathology with advanced Artificial Intelligence (AI) technology to create value for the oncology team.
Paige is the first company to develop clinical grade AI technology for the pathologist, which resulted in our receiving FDA breakthrough designation for our first product.
We are seeking a passionate Director of Regulatory & Quality to join our team. You must have the knowledge and experience to understand the appropriate regulations, with the passion and capability to implement a QMS in a lean method suitable to an agile software development organization. As Director of Regulatory & Quality, you will be working closely with key stakeholders across the company, you will be responsible for driving and managing regulatory strategy and obtaining regulatory approvals across a range of products as well as maintaining and improving our quality management system. This position requires ensuring compliance with existing and upcoming regulations applicable in the US, Europe and South America. You will be responsible for working closely with leadership to align regulatory strategy with product strategy. This is an excellent opportunity as a hands-on, yet strategic, position in a dynamic and fast-growing company.
- Create and execute Regulatory Strategies and Plans for assigned products in the domestic and international markets.
- Support and provide regulatory expertise to assigned product development projects.
- Maintain expertise in the interpretation of domestic and foreign regulations and laws as they apply to the licensing, registration, manufacture, shipping, and sale of assigned products.
- Prepare and submit 510(k)'s, IDE's, registration and listing, and other product submissions according to FDA guidelines as well as any required reporting.
- Creating Technical File and Declaration of Conformity documents and other relevant regional submissions according to IVDD and other international guidelines.
- Review and approve product labeling plans, labeling, and marketing communications and assure claims are substantiated.
Quality Assurance and Quality Control
- Manage and improve the Paige Medical Device Quality Management System (QMS) function ensuring compliance with applicable laws, regulations, and standards for a medical device
- Verify and maintain quality control records and documents.
- Establish and actively direct quality management sub-systems to achieve continual compliance and consistency that include: Deviations, CAPA, Document Control, Process control, Supplier management, Training, etc
- Perform internal quality management reviews and internal audits to ensure the Paige QMS remains compliant with national and international standards for medical devices.
- Provide guidance and participate where appropriate in Feasibility, Development, Design Verification, Design Validation, Design Transfer, and Commercialization reviews and activities from a quality and documentation perspective.
- Recommend and coordinate implementation and effectiveness of any resulting or otherwise needed corrective and preventive actions.
- Facilitate audits by external auditors and certifying bodies to verify compliance of quality management system, security, risk and other required standards.
- Work with the rest of the Paige team to implement and maintain a process for continual improvement of customer satisfaction, product and service quality, and process performance.
- Ensure personnel are trained and competent to perform their role(s) and capable of producing quality products.
- Perform quality orientation and quality trainings to staff throughout the year, as needed.
Qualifications and Experience
- ABS or equivalent in Engineering, Life Sciences or other similar technical field. Master’s degree preferred. Regulatory Certificate or RAC preferred.
- Minimum of 6-8 years of experience within Medical Device industry. Duties and tasks reflect variety and complexity.
- Excellent knowledge of ISO13485, ISO27001, EU and FDA requirements, with experience supporting regulatory submissions and technical files.
- Proven track record of preparing for and managing successful Quality audits/inspections.
- Quality system and regulatory experience with Software as a Medical Device (SAMD) preferred.
- Experience with LDTs preferred.
- Experience with clearance of medical devices outside of the US and the EU preferred.