RQAP-GCP (Registered Quality Assurance Professional – GCP)
4 Year Degree
Oversees and manages direction of global regulatory affairs and quality assurance functions. This includes regulatory submissions, interactions with regulatory agencies (including FDA and Notified Body), regulatory compliance, quality certifications, overall responsibility for the quality system as Management Representative to support the safety and efficacy of iCAD products.
This position reports directly to the President and ensures that QA/RA activities are planned; that resources are allocated; priorities are established, and activities are executed to meet business goals.
• Establish, manage implementation of, and continuously improve the company’s quality management system to assure that it is operating effectively and efficiently. • Ensure that the Company’s quality management system is implemented in accordance with internal procedures and complies with external requirements such as: ISO 13485, European Medical Device Regulations and FDA Quality System Regulations. • Secure world-wide regulatory approvals for the company’s products in conformity with the European Medical Devices Directive - 93/42/EEC, FDA’s PMA, PMA supplement, and 510(k) submissions regulations, and international (e.g. Health Canada) licensing requirements. Obtain product approvals, certifications and licenses where necessary for US and worldwide market release. • Oversee the international regulation process for company products by ensuring that all necessary submissions/applications are filed and by managing all necessary interactions with government agencies. • Interpret FDA and other regulatory laws and standards; update the company’s quality management system and regulatory practices as necessary to ensure continuous compliance of company operations. • Oversee internal and external quality audits and work closely with operations staff to reinforce adherence to company standard operating procedures. • Support planning and execution of clinical trials in support of Class II and Class III regulatory filings in accordance with Good Clinical Practices (GCP) • Support development of policies and standard operating procedures to ensure regulatory compliance of company operations. • Report on quality system performance and compliance status to Senior Management and implement improvements as necessary. • Monitor, investigate and ensure resolution of quality problems with products, processes, and/or the quality management system. • Oversee release of the company’s finished products for commercial distribution; ensure that all released products meet their specifications. • Oversee review and approval of product labeling and promotional materials to ensure that they conform to regulatory requirements. • Promote awareness of regulatory and customer requirements throughout the organization.
• Requires a bachelor's degree with at least 15 years of progressive quality systems/regulatory affairs leadership experience in the medical device industry. • International regulatory experience is a must! • Experience with FDA Class II, software controlled medical devices is required; Class III medical device experience is highly preferred. • MS in technical field preferred. • Direct experience in establishing and maintaining corporate procedures as they relate to the FDA Quality System Regulations, ISO 13485, the Medical Device Directive 93/42/EEC and the EU Medical Device Regulations. • Experience coordinating and creating documentation for regulatory submissions, including: 510(k), PMA, PMA Supplements and PMA annual reports (United States; FDA), technical file (European Community; CE Mark) or international license applications. • Must have a working knowledge of Good Clinical Practices (GCP). • Experience working in a developmental engineering environment, creating and documenting prototype devices and providing support through design and manufacturing phases regarding FDA regulatory, documentation, testing and inspection requirements. • Ability to guide the implementation of design controls with emphasis on the creation of Hazard/Risk Analysis, Failure Mode and Effects Analysis (FMEA), and design history file / design review documentation. • Must have the ability to interpret regulatory standards. • Positive attitude and a team player with exceptionally good interpersonal skills and ability to communicate with highly specialized research and development scientists, engineers and marketing people is a must. • Excellent verbal and written communication skills.
About iCAD, Inc.
iCAD is a global leader in advanced breast cancer detection solutions built on artificial intelligence that empower radiologists to find cancers earlier while improving reading workflow. Our Breast Health Solutions suite delivers powerful detection and workflow solutions for 2D and 3D mammography.
For more information, visit www.icadmed.com or www.xoftinc.com.