Senior Regulatory Strategist – Global MedTech & SaMD | Remote

Clinisys; Horsell; On-site; GBP 70,000 - 110,000; Full time

Job summary

Clinisys is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities across global markets throughout the product lifecycle. You will collaborate with Quality, Clinical Safety, Product Management, R&D and Legal to shape regulatory strategy and submissions.

You will prepare filings, assess changes, and guide cross-functional teams through audits, registrations and market access. A strong background in medical devices or healthcare software is essential.

Qualifications

• Bachelor's degree in a scientific, engineering, healthcare, regulatory affairs or related discipline.
• 5+ years' Regulatory Affairs experience within a regulated industry.
• 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

Regulatory submissions

Regulatory strategy

Stakeholder management

Communication skills

Organisational skills

Education

Bachelor's degree in a scientific or regulatory discipline

Regulatory Affairs Certification (RAC)

Tools

AI-enabled tools

Job description

Clinisys is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities across global markets throughout the product lifecycle. You will collaborate with Quality, Clinical Safety, Product Management, R&D and Legal to shape regulatory strategy and submissions.

You will prepare filings, assess changes, and guide cross-functional teams through audits, registrations and market access. A strong background in medical devices or healthcare software is essential.