Building an AI‑first organisation is central to Clinisys’ purpose and the impact we deliver. As a global provider of intelligent diagnostic informatics solutions, we build AI‑enabled, cloud‑based platforms to enhance diagnostic workflows across healthcare, life sciences, and public health. By applying intelligent technology thoughtfully and responsibly, we help laboratories and testing environments operate more effectively, generate meaningful insights at scale, and ultimately support healthier and safer communities. Operating across more than 30 countries, Clinisys expects all colleagues—regardless of role or function — to work confidently with AI‑enabled tools, apply digital and analytical thinking, and continuously adapt as technologies evolve, must drive an AI first sense of purpose and urgency.
Clinisys has built an unrivalled reputation for deploying complex diagnostic networks and academic centres – and is the only provider to repetitively deliver to all disciplines end-to-end – at scale. Fostering healthier communities.
As a Senior Regulatory Affairs Specialist, you will support Clinisys' global regulatory activities, ensuring compliance across multiple international markets and regulatory frameworks.
Working closely with Quality, Clinical Safety, Product Management, R&D, Operations and Legal teams, you'll provide regulatory expertise throughout the product lifecycle, from product development and market access through to post-market compliance. You'll play a key role in regulatory submissions, product registrations, change assessments and regulatory strategy, helping Clinisys navigate an evolving global regulatory landscape.
This role requires a working knowledge of Artificial Intelligence (AI) technologies and the ability to leverage them to improve processes and outcomes. A core understanding of AI concepts is required and must be able to demonstrate the use of AI tools in a professional setting.
As part of our onboarding process, all new employees will be required to attend / travel to the office on their first day of employment. This requirement is essential for onboarding activities, including the identity verification, completion of necessary documentation, receiving your IT equipment, introductions to key team members, and orientation to Clinisys policies and procedures.
#LI-AD #LI-REMOTE
*Clinisys acquired Orchard Software July 2025 (see press release https://tinyurl.com/clinisysnews)*
Clinisys delivers over 45 years of laboratory informatics expertise – built through the combined strength of trusted companies and specialists brought together under one global brand.
Today, we support more than 7,000 labs across 39 countries, helping them manage data, maximize throughput, and ensure quality across healthcare, contract services, public health, water quality, environmental sciences, toxicology, crop science, food & beverage, and life sciences industries. With our newest addition of proven solutions, we’ve also expanded our reach into physician office, reference, and veterinary laboratories, further strengthening our commitment to excellence and innovation.
In the future, we aim to expand into biotech and pharma to continue growing our mission of enabling healthier and safer communities.
Our solutions are designed to scale for the evolving needs of modern labs, and we’re committed to supporting every type of laboratory or remote testing environment – from public or private sector, in-house or outsourced. With headquarters in Tucson, AZ, and key offices in Raleigh, NC, Carmel, IN, Ghent BE, Woking UK, Bangalore IN, Kolkata IN, and across Europe, Clinisys is proud to be the global leader in lab informatics, holding ~24% of the global market share.
At our core is a people-first culture – driven by passionate experts who’ve spent decades helping labs run smarter and more efficiently.
Informatics is more than technology; it’s our path to a more connected, resilient, and thriving world.
𝗗𝗶𝘀𝗰𝗼𝘃𝗲𝗿 𝗵𝗼𝘄 𝗖𝗹𝗶𝗻𝗶𝘀𝘆𝘀 𝗶𝘀 𝘁𝗿𝗮𝗻𝘀𝗳𝗼𝗿𝗺𝗶𝗻𝗴 𝗹𝗮𝗯 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗰𝘀 – 𝗰𝗼𝗻𝗻𝗲𝗰𝘁 𝘄𝗶𝘁𝗵 𝘂𝘀 𝗮𝗻𝗱 𝗯𝗲 𝗽𝗮𝗿𝘁 𝗼𝗳 𝘁𝗵𝗲 𝗳𝘂𝘁𝘂𝗿𝗲 𝗼𝗳 𝗴𝗹𝗼𝗯𝗮𝗹 𝗵𝗲𝗮𝗹𝘁𝗵.
