Regulatory Intelligence Manager

Optos PLC; Dunfermline; Presencial; GBP 70.000 - 110.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory submissions

Regulatory intelligence

Stakeholder management

Regulatory compliance

Presentation skills

English (fluency)

Risk assessment

Educación

Degree or equivalent in sciences/engineering/quality management

Descripción del empleo

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 9001/13485 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