The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
We currently have a great opportunity available for a Software Design Control & Validation Director. This position will prepare any FDA submission paperwork and required certificates or licenses for US and non-US governments, investigate new products for potential FDA submissions, participate on new product launch teams and monitor clinical trials where needed. In addition, develop CFR compliance guidance strategies where needed. Support ISO maintenance activities performing internal/external audits. Research and communicate any new or changes to regulations. Provide compliance training and support FDA inspection activities as needed. The overall purpose of this position is to effectively manage both the day-to-day activities and strategic quality planning for Sysmex Reagents of America (SRA).
Essential Duties and Responsibilities:
Ensure compliance of Sysmex America’s and Sysmex Reagents America businesses, including FDA, ISO, and Health Canada / Canadian Medical Device Regulations.
Responsible for all software validation-related activities associated with Sysmex America and Sysmex Reagent America businesses including, but not limited to, new factory equipment, infrastructure and processes, SAI IVD and Health IT products and Corporate Support Systems such as CRM, ERP and other internal /” home grown” systems used to support the sales, service and supply chain activities of the Americas business.
Representation and guidance at New Product Launch teams for Quality Systems-related topics, as required.
Participate in and facilitate (as required) FDA, HC, ISO, Customer and Supplier audits and inspections Have knowledge of department and corporate procedures and processes to ensure the most vigorous defense to Compliance and Regulatory bodies.
Drive continual improvement activities from a Design Control and Validation Services perspective. Maintain clear, concise and well-defensible files of Validation documentation to facilitate Regulatory and Compliance-related inspections.
Lead Key Associate Training activities associated with this area of SAI’s and SRA’s business. Mentor and develop direct reports to support business change and growth.
Drive cross functional culture change in the adoption of Design Control and Validation processes, as well as compliant record keeping in support of software products.
Drive adoption of Design Control and Validation process requirement across the Sysmex Corporate network.
Provide Quality oversight and guidance to Sysmex America’s Marketing & Promotional materials to ensure compliance with FDA labeling guidelines and requirements.
Responsible for performing impact analysis and managing through potential field safety issues related to software product defects.
Physical Risk: Regular exposures to risk that may require special training and precautions.
Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.
Percentage of Travel: 5 – 15%
Bachelor’s Degree in Science with at least 15 years’ experience in medical device industry, working within quality system framework for SW design controls and validation.
At least 15 years total career experience.
Knowledge of cGMP (FDA and HC QSR) and ISO regulations.
Microsoft Word, Outlook, Excel, PowerPoint, Access.
In depth understanding of Design Controls and Validation requirements in support of Software products.
Strong communication and interpersonal skills.
Ability to obtain cooperation, develop a consensus and lead or influence cross-functional teams.
Positive “can do” attitude who has the capability to be promoted to Director Position.
In conjunction with corporate staff, develop and formulate final decisions on key regulatory and compliance issues affecting Sysmex products, services and customer support issues.
In conjunction with Corporate, manage departmental budget and objectives to achieve business goals and project timelines.
Must be able to assimilate relevant technical, regulatory and compliance information and formulate suitable strategies and tactics to satisfactorily resolve complex problems.
Strong practical knowledge of compliance and regulatory environments. Knowledge of hematology products and marketplace preferred but not required.
Internal Number: 2020-1947
Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.