Optos
Regulatory Intelligence Manager
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ABOUT US
When a five-year-old boy was blinded after a regular eye exam failed to spot a retinal detachment, his father made it his life’s work to help eye care professionals by revolutionising retinal imaging.
Optos was founded by Douglas Anderson with the goal to make a patient-friendly device to capture a digital ultra-widefield image of the retina. Today, millions of patients around the world have benefited from optomap® retinal imaging.
Acquired by Nikon Corporation in 2015, Optos now operates within the Nikon Healthcare division. The company recently celebrated its 30th anniversary and is recognised as a leading provider of advanced imaging devices that support a more complete approach to patient care. Optos generates approximately $300 million in revenue, employs around 650 people worldwide, and manufactures 60% of its products in the UK.
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. Requiring proactive risk identification, and ensuring that compliance is maintained whilst supporting efficient regulatory submissions.
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ESSENTIAL DUTIES AND 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.
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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.
- Good computer skills (MS Office applications).
- Experience in Clinical Trials of Medical Devices.
- Fluent English both written and oral is essential.
If you feel you have the necessary skills and experience and want to join a great team, please click on the Apply button!
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