Global Regulatory Intelligence Lead - Medical Devices

Optos PLC; Dunfermline; On-site; GBP 70,000 - 110,000; Full time

Job summary

Optos PLC in the United Kingdom seeks a Regulatory Intelligence Manager to identify, monitor, and interpret evolving regulatory requirements across global markets. You will translate regulatory intelligence into actionable guidance, support compliance, risk management, and product lifecycle activities for hardware and software portfolios.

You will lead end-to-end intelligence processes, engage with authorities, and provide strategic guidance to cross-functional teams, ensuring timely and

Qualifications

• Degree or equivalent in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences.
• Excellent practical experience of regulatory submissions and requirements.
• Widespread experience in the highly regulated medical device market.
• Good awareness of FDA & MHRA systems and procedures.
• Direct experience with Medical Device approvals, specifically with clinical trial requirements.
• Excellent presentation skills are required.
• Experience in Clinical Trials of Medical Devices.
• Fluent English both written and oral is essential.

Responsibilities

• Manage end-to-end global monitoring of regulatory developments and policy changes.
• Design and improve a structured regulatory intelligence surveillance process.
• Build and maintain relationships with internal stakeholders and external partners.
• Embed regulatory intelligence into project and product team decision-making.
• Provide strategic advice on regulatory planning, risk, and lifecycle considerations.
• Monitor competitor activity and industry developments and integrate outputs.
• Assess regulatory changes and their impact on products and business strategy.
• Lead on global regulatory developments and implement clear action plans with teams.
• Engage with authorities (MHRA, EMA, FDA) for clarification and alignment.
• Develop metrics, dashboards, and summaries for Senior Leadership.
• Define, implement, and track Regulatory Intelligence KPIs.

Skills

Regulatory submissions

Regulatory intelligence

Stakeholder management

Regulatory compliance

Presentation skills

English (fluency)

Risk assessment

Education

Degree or equivalent in sciences/engineering/quality management

Job description

Optos PLC in the United Kingdom seeks a Regulatory Intelligence Manager to identify, monitor, and interpret evolving regulatory requirements across global markets. You will translate regulatory intelligence into actionable guidance, support compliance, risk management, and product lifecycle activities for hardware and software portfolios.

You will lead end-to-end intelligence processes, engage with authorities, and provide strategic guidance to cross-functional teams, ensuring timely and