Quality & Regulatory Expert in AIaMD Ireland · Hybrid Remote

Quality & Regulatory Expert in AIaMD (Artificial Intelligence as a Medical Device) Date: ASAP Work Type: Please note this work will be ad-hoc and not for a set amount of hours or time period. You will conduct audits and trainings as desired by our clients as suited around your other ongoing work as a current consultant/employee. Location: Europe or USA Role: Quality & Regulatory Expert in AIaMD (Artificial Intelligence as a Medical Device) We are looking for a proven regulatory and quality expert to help companies and their employees develop and cultivate their skills and knowledge in AI. You will provide your expertise in ways that improve the company and its employees. You will be an experienced professional and educator, who can understand the complex quality and regulatory issues that companies face. You should be able to answer complex questions and give guidance when needed. Your abilities to convey a message should only be surpassed by a deep knowledge of your field. Organizational skills and a positive attitude are important qualities that you have to possess. Responsibilities:

• Liaise with customers to determine their expert guidance requirements, audit requirements and scheduling of audits.
• Deliver expert guidance and input that will have a positive impact for the company. This may be in person, or remote Online.
• Deliver effective audits. This may be in person, or remote Online.
• Prepare materials such as agendas, final reports and any supporting documentation.
• Keep attendance and other records.

Role Requirements:

• Experience as an educator and auditor is essential.
• BEng/BSc/BA or above in a relevant field with demonstrated expertise in AI.
• Relevant industry experience, preferably gained in more than one company.
• Experience with ISO13485 & IEC62304, Product design (with emphasis on AI software design and strong focus on App design incorporating AI), MDR (with emphasis on SaMD, software risk determination, GSPRS’s applicable to software, Rule 11, software documentation requirements and UDI for software)
• Experience working for a notified body would be an advantage.
• Demonstrate a willingness to keep abreast of industry changes.
• Proficient in MS Office (esp. PowerPoint) and Zoom.
• Phenomenal communication, presentation and public speaking skills.
• Professional demeanour and appearance.
• Excellent organizational and time management abilities.
• Excellent critical thinking and decision making.

Remote status Hybrid Remote

Ireland

Our Company Culture

People First, Always Trinzo is a company driven by unshakeable core values: we put people first, from our consultants to our clients, and we value hard work, honesty and integrity above all. At Trinzo, we strive to create a company culture that encourages each member of the consultancy ecosystem to reach their fullest potential, whether that’s a client with an organizational issue or a consultant with a vision for change. We help our team to lead the industry in creating solutions, applying well-tested methodologies and persistently seeking innovative ways to help our clients succeed.

About Trinzo

Trinzo is a medical device and pharmaceutical consultancy firm that excels at compliance, regulatory and project management issues. We create bespoke solutions for our clients on a project basis and find the root of structural issues. In many cases, our clients hire us to solve a specific problem or remediate an issue. Sometimes, the issue at hand is only surface-level and our knowledgeable consultants use their industry expertise to design a comprehensive solution. But when the challenges run deeper, Trinzo will get to the heart of the issue, offering insight, advice and industry-leading methodologies that will leave your team stronger, with renewed motivation and increased efficiency. #J-18808-Ljbffr