Regulatory Intelligence Manager

Optos; Dunfermline; On-site; GBP 70,000 - 90,000; Full time

Job summary

Optos, based in Dunfermline, UK, seeks a Regulatory Intelligence Manager to lead global monitoring of evolving regulatory requirements, health authority expectations, and industry trends. You will translate intelligence into actionable guidance that informs regulatory strategy, submissions, and lifecycle planning for hardware and software portfolios.

Responsibilities include building surveillance processes, coordinating cross-functional teams, and communicating regulatory insights with senior

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.
• Previous Knowledge of ISO / system is essential
• Knowledge of cGMP / Quality System Regulations is essential
• 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, guidance, enforcement trends, and policy changes across key health authorities, leveraging Medboard as the primary intelligence source.
• Design, implement, and continuously improve a structured regulatory intelligence surveillance process, ensuring consistent and efficient capture, triage, and dissemination of insights from global sources.
• Build and maintain effective relationships with internal stakeholders and external partners, ensuring clear, timely, and impactful communication of regulatory intelligence.
• Lead and coordinate cross-functional activities to embed regulatory intelligence into project and product team decision-making, strengthening regulatory understanding across the organisation.
• Provide strategic advice and guidance to stakeholders on regulatory planning, risk, and lifecycle considerations for assigned products and projects.
• Conduct ongoing monitoring of competitor activity and wider industry developments, integrating Medboard outputs with broader research to deliver comprehensive intelligence.
• Assess and interpret regulatory changes, determining their impact on products, processes, and overall business strategy across global markets.
• Provide leadership and direction on global regulatory developments, translating intelligence into clear, actionable implementation plans in collaboration with cross-functional teams, including identification of gaps and mitigation actions
• Engage with regulatory authorities (e.g. MHRA, EMA, FDA) where required to support clarification, alignment, and strategic positioning
• Develop and deliver regular metrics, dashboards, and summary reports to the Senior Leadership Team, highlighting key risks, trends, and opportunities.
• Define, implement, and track Regulatory Intelligence KPIs to measure effectiveness, timeliness, and business impact of intelligence activities.

Skills

Excellent presentation skills

Fluent English

Experience regulators submissions

Education

Degree in sciences or related field

Job description

Regulatory Intelligence Manager Optos Dunfermline, GB, KY11 8GR

ROLE SUMMARY

The Regulatory Intelligence Manager is responsible for supporting the global identification, monitoring, and interpretation of evolving regulatory requirements, health authority expectations, and industry trends, translating regulatory intelligence into clear, actionable guidance that informs regulatory strategy. Provides expert leadership on regulatory state of the art, supporting compliance, risk management, market access, and product lifecycle activities across hardware and software portfolios. Ensures regulatory insights are effectively integrated into submissions, technical documentation, and business processes, driving informed decision-making and continuous improvement across the organisation. Requring proactive risk identification, and ensuring that compliance is maintained whilst supporting efficent regulatory submissions.

ESSENTIAL DUTIES AND RESPONSIBILITES

• Manage end-to-end global monitoring of regulatory developments, guidance, enforcement trends, and policy changes across key health authorities, leveraging Medboard as the primary intelligence source.
• Design, implement, and continuously improve a structured regulatory intelligence surveillance process, ensuring consistent and efficient capture, triage, and dissemination of insights from global sources.
• Build and maintain effective relationships with internal stakeholders and external partners, ensuring clear, timely, and impactful communication of regulatory intelligence.
• Lead and coordinate cross-functional activities to embed regulatory intelligence into project and product team decision-making, strengthening regulatory understanding across the organisation.
• Provide strategic advice and guidance to stakeholders on regulatory planning, risk, and lifecycle considerations for assigned products and projects.
• Conduct ongoing monitoring of competitor activity and wider industry developments, integrating Medboard outputs with broader research to deliver comprehensive intelligence.
• Assess and interpret regulatory changes, determining their impact on products, processes, and overall business strategy across global markets.
• Provide leadership and direction on global regulatory developments, translating intelligence into clear, actionable implementation plans in collaboration with cross-functional teams, including identification of gaps and mitigation actions
• Engage with regulatory authorities (e.g. MHRA, EMA, FDA) where required to support clarification, alignment, and strategic positioning
• Develop and deliver regular metrics, dashboards, and summary reports to the Senior Leadership Team, highlighting key risks, trends, and opportunities.
• Define, implement, and track Regulatory Intelligence KPIs to measure effectiveness, timeliness, and business impact of intelligence activities.

MINIMUM QUALIFICATION

• 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.
• Previous Knowledge of ISO / system is essential
• Knowledge of cGMP / Quality System Regulations is essential
• 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