Global Regulatory Intelligence Lead (Medtech)

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

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