Medical Device, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
Now part of the Hill-Rom family of companies, Mortara Instrument is the fastest-growing company in its field and the number two provider of ECG devices in the world. With operations in Australia, Germany, Italy, the Netherlands, and the United Kingdom, Mortara distributes its innovative products worldwide to physician offices, clinics and hospitals. Its offerings include electrocardiographs, cardiac stress exercise and rehabilitation systems, Holter systems, data warehousing solutions, and patient monitoring systems. With a deep commitment to both its customers and community, Mortara is proud of its unique, “Built with Pride in Milwaukee” philosophy, which is the driving force behind its commitment to manufacturing products in the U.S. Mortara also offers an excellent benefits package including health, dental, disability and life insurance, flex spending and health savings accounts, paid time off/paid holidays, and a 401(k)-retirement plan with employer match.
This position acts as a liaison between Global Regulatory Affairs and Engineering, providing technical interpretation of domestic and international regulatory requirements for new product launches and changes throughout the product lifecycle. Responsible for identifying and planning ongoing maintenance tasks required to maintain product licenses and registrations.
Works closely with Global Regulatory Affairs to identify applicable regulatory requirements, and to translate the requirements into work tasks for Engineering development and maintenance plans.
Understands new and changing regulations identified by Global Regulatory Affairs. Determines the impact on new product development/maintenance activities and effectively communicates the outcome to Engineering.
Serves as a resource to the engineering teams during product development to ensure the necessary steps are taken during a project for successful product registrations.
Works with Engineering to develop productive verification and validation strategies needed for a successful regulatory registration.
Participates in the planning and executing product safety and performance standards (e.g., UL, CSA, IEC and ANSI/AAMI.) with third-party laboratories.
Collaborates with Global Regulatory Affairs to understand “current thinking” of regulatory agencies and to assist Engineering in applying US FDA, European MEDDEV, etc. guidance documents to their designs.
Comprehends new technologies or design concepts and works with Global Regulatory Affairs to identify applicable regulations and standards.
Accurately populates and maintains the global registration database, to ensure maintenance activities are planned for by Engineering to sustain compliance through a product’s lifecycle.
Evaluates product design changes and, working with Global Regulatory Affairs, determines impact on existing product registrations and licenses.
Supports Global Regulatory Affairs personnel during product registrations.
Assists Quality Assurance and Regulatory Affairs during audits conducted by regulatory agencies.
Assists Sales and Marketing in responding to technical questions arising from tenders or other sales efforts.
Performs other duties as requested.
BS in Engineering or equivalent four-year degree.
At least 5 years relevant work experience in the medical device field.
Strong working knowledge of standards relevant to medical device safety and performance; experienced with IEC 60601 standards.
Strong technical acumen, including ability to read and understand product, hardware and software requirement documents, design description documents, etc.
Previous US 510(K) and Health Canada submission experience is preferred.
Excellent interpersonal and verbal/written communication skills. Fluent in English.
Strong analytical skills.
Ability to work well both individually and in groups.
Calm under pressure. Good listening skills.
Proactive, flexible and adaptable. Able to learn new skills and concepts quickly.
Good organizational and planning skills. Detail orientated.
Ability to manage time and prioritize work.
Must possess strong decision making and problem solving skills.
Must be able to work with minimal direction, be highly motivated, and be a team player.
Advanced Microsoft Office skills including: Word, Outlook, Excel, Visio and PowerPoint.
Comfortable working with ambiguity and change. Must be able to work in a fast pace environment.
Must be a team-player, possess outstanding customer service skills and be self-motivated.
Acts with a sense of urgency, illustrates ambition, and drives for completion of task and projects.
Must have the ability to initiate and develop creative solutions.
Possess the ability to manage time and prioritize critical priorities.
Must demonstrate the ability to increase knowledge.
Physical demands and work environment:
Physical Demands: While performing the duties of this job the employee will be sitting for extended periods, will need to use a computer/mouse/keyboard/monitor and will communicate and listen both in-person and over the phone.
Work environment: The work environment is in an office setting and has a minimal noise level.
Internal Number: 17124110
About Hill-Rom/Mortara Instrument
For over 30 years, Mortara has served as a leading designer, developer and manufacturer of medical devices and technologies. Today, the Company is the fastest-growing company in its field and the number two provider of ECG devices in the world. With operations in Australia, Germany, Italy, the Netherlands, and the United Kingdom, Mortara distributes its innovative products worldwide to physician offices, clinics and hospitals. Its offerings include electrocardiographs, cardiac stress exercise and rehabilitation systems, Holter systems, data warehousing solutions, and patient monitoring systems. Mortara currently has approximately 400 employees and is constantly looking to expand its talented workforce.
Mortara employees benefit from a corporate culture that is rooted in giving back to the community. With a deep commitment to both its customers and community, Mortara is proud of its unique, “Built with Pride in Milwaukee” philosophy, which is the driving force behind its commitment to manufacturing products in the U.S. The company offers an exciting opportunity to work in a stimulating, team-oriented environment where individual contributions are both recognized and rewarded.... The organization fosters a culture of excellence, innovation, diversity and growth. The Mortara team is family-oriented, with a focus on both wellness and community. Mortara also offers an excellent benefits package including health, dental, disability and life insurance, flex spending and health savings accounts, paid time off/paid holidays, and a 401(k) retirement plan with employer match. Visit our web site at www.mortara.com or follow us on LinkedIn to see what’s happening within our organization.