Regulatory Intelligence Lead, Medical Devices

Kleboe Jardine Ltd

Scotland

On-site

GBP 70,000 - 110,000

Full time

13 days ago

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Job summary

Kleboe Jardine Ltd in the United Kingdom is seeking an experienced Regulatory Intelligence Manager to strengthen its global Regulatory Affairs capability in medical devices. You will identify and translate evolving regulatory requirements and authority expectations into actionable plans that shape product strategy and market access.

You will work across Regulatory Affairs, Quality, Clinical and Product Development, reporting to senior leadership.

Qualifications

Experience in medical device regulatory submissions and approvals.
Strong understanding of international regulatory requirements.
Excellent written and spoken English.
Occasional travel to international markets.

Responsibilities

Monitor global regulatory developments, guidance, standards, enforcement trends and health authority expectations.
Assess the potential impact of regulatory changes on products, technical files, processes, clinical activity and market access.
Translate complex regulatory developments into clear recommendations, implementation plans and risk-mitigation actions.
Develop and improve structured regulatory intelligence and surveillance processes.
Provide strategic regulatory advice to product and project teams throughout the product lifecycle.
Monitor competitor activity and wider medical device industry developments.
Support regulatory strategy for new and existing products across international markets.
Work with authorities including the MHRA, EMA and FDA where appropriate.
Produce dashboards, metrics and senior-management reports covering emerging risks, opportunities and regulatory trends.
Establishing and monitoring Regulatory Intelligence KPIs to demonstrate impact and effectiveness of the function.