Senior Regulatory Strategist – Global SaMD Submissions

Clinisys; Woking; On-site; GBP 65,000 - 90,000; Full time

Job summary

Clinisys seeks a Senior Regulatory Affairs Specialist to drive global regulatory activities across markets and frameworks. You will partner with Quality, Clinical Safety, Product Management, R&D, Operations and Legal to guide submissions, registrations and post-market compliance throughout the product lifecycle.

You will lead regulatory strategy, manage risk, and influence cross-functional teams on market access and regulatory changes, including AI-enabled tooling in regulatory research.

Qualifications

• 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 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.

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.

Skills

Regulatory affairs

FDA/EU MDR knowledge

Regulatory submissions

Audits & inspections

Stakeholder management

SaMD experience

Education

Bachelor's degree in a scientific, engineering, healthcare, regulatory affairs or related discipline

Job description

Clinisys seeks a Senior Regulatory Affairs Specialist to drive global regulatory activities across markets and frameworks. You will partner with Quality, Clinical Safety, Product Management, R&D, Operations and Legal to guide submissions, registrations and post-market compliance throughout the product lifecycle.

You will lead regulatory strategy, manage risk, and influence cross-functional teams on market access and regulatory changes, including AI-enabled tooling in regulatory research.