Regulatory Intelligence Manager

Optos; Dunfermline; On-site; GBP 90,000 - 130,000; Full time

Job summary

Optos is seeking a Regulatory Intelligence Manager to lead global monitoring of evolving regulatory requirements, health authority expectations, and industry trends across hardware and software products. Translate insights into clear, actionable guidance that informs regulatory strategy and lifecycle decisions.

You will design a structured surveillance process, collaborate with internal stakeholders, and ensure that regulatory intelligence informs submissions, technical documentation, and

Qualifications

• Degree in sciences, engineering or quality management; equivalent education via experience.
• Excellent practical experience of regulatory submissions and requirements.
• Widespread experience in the regulated medical device market.
• Knowledge of FDA & MHRA systems and procedures.
• Proficiency with ISO quality systems and cGMP basics.
• Direct experience with medical device approvals and clinical trial requirements.
• Excellent presentation skills and strong communication.
• Good computer skills (MS Office).
• Fluent English written and spoken.

Responsibilities

• Lead end-to-end global monitoring of regulatory developments and policy changes.
• Design and maintain a structured regulatory intelligence process.
• Communicate insights to stakeholders with clear, actionable guidance.
• Embed regulatory intelligence into project decisions and product lifecycles.
• Advise on regulatory planning, risk, and lifecycle considerations.
• Monitor competitor activity and broader industry developments.
• Assess impact of regulatory changes on products, processes and strategy.
• Engage with regulatory authorities to support alignment and positioning.
• Deliver metrics, dashboards and summaries to Senior Leadership.
• Define and track regulatory intelligence KPIs and business impact.

Skills

Fluent English

Regulatory knowledge

Medical device regulatory experience

FDA / MHRA familiarity

Clinical trial requirements knowledge

Education

Degree in sciences / engineering / quality management

Tools

MS Office

Job description

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.


• Good computer skills (MS Office applications).


• Experience in Clinical Trials of Medical Devices.


• Fluent English both written and oral is essential