Clinisys
Senior Regulatory Specialist
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Building an AI-first organisation
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.
Job Overview
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.
Responsibilities
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- Lead regulatory activities for assigned product portfolios, developing strategies that support global market access, product lifecycle management, and business objectives.
- Act as the Regulatory Affairs subject matter expert, providing guidance throughout the product lifecycle, including product development, software releases, design changes, commercialisation, post-market activities, and market expansion.
- Lead the preparation, review, and submission of regulatory filings, registrations, certifications, and market access activities across global jurisdictions.
- Assess the regulatory impact of product changes, emerging regulations, and industry standards, translating regulatory requirements into practical business recommendations.
- Identify and mitigate regulatory compliance risks, supporting risk-based decision-making and ensuring ongoing compliance with global regulatory requirements.
- Lead regulatory workstreams within cross-functional projects, influencing stakeholders across Product, R&D, Quality, Clinical Safety, Commercial, and Operations teams.
- Represent Regulatory Affairs during audits, inspections, customer due diligence activities, and interactions with regulatory authorities, notified bodies, and certification bodies.
- Support the continuous improvement of regulatory processes, governance, and compliance frameworks.
Essential Experience
- Bachelor's degree in a scientific, engineering, healthcare, regulatory affairs, or related discipline.
- 5+ years' Regulatory Affairs experience within a regulated industry, ideally medical devices, diagnostics, healthcare software, digital health, or life sciences.
- Experience preparing, supporting, or managing regulatory submissions, registrations, certifications, and market access activities.
- Experience supporting regulatory compliance throughout the product lifecycle.
- Strong knowledge of global regulatory requirements, including FDA, EU MDR, IVDR, UK Medical Device Regulations, and associated standards such as ISO 13485, ISO 14971, and IEC 62304.
- Experience supporting audits, inspections, and interactions with regulatory or certification bodies.
- Excellent communication, stakeholder management, and organisational skills.
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Desirable Experience
- Regulatory Affairs Certification (RAC) or equivalent.
- Experience with Software as a Medical Device (SaMD), healthcare software, laboratory systems, diagnostics, or digital health technologies.
- Experience supporting products across multiple international markets.
- Previous experience in a technical, scientific, quality, or operational role before moving into Regulatory Affairs.
- Experience using AI-enabled tools to support regulatory research, monitoring, and compliance activities.
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.
Onboarding
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.
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