Senior Regulatory Specialist

Clinisys

1d • Remote

About The Position

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. Clinisys is an AI-first organization, and 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.

Requirements

• 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.
• A core understanding of AI concepts is required and must be able to demonstrate the use of AI tools in a professional setting.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• Onboarding process includes attending/traveling to the office on the first day for identity verification, documentation completion, IT equipment receipt, team introductions, and orientation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior