Kleboe Jardine Ltd
Regulatory Intelligence Manager
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Regulatory Intelligence Manager
We are supporting an established and innovative medical technology business with the appointment of a Regulatory Intelligence Manager to strengthen its global Regulatory Affairs capability.
This is a strategically important role responsible for identifying, interpreting and communicating emerging regulatory requirements, health authority expectations and industry developments across global markets. The successful candidate will translate regulatory intelligence into clear, practical actions that influence product strategy, lifecycle management, technical documentation, submissions and market access.
The role will suit an experienced regulatory professional who enjoys looking beyond individual submissions and taking a broader view of how changes in regulation may affect products, processes and commercial strategy. You will act as a central point of expertise for regulatory intelligence, working closely with Regulatory Affairs, Quality, Clinical, Product Development and senior leadership teams across a portfolio incorporating both medical device hardware and software.
Key responsibilities will include:
- Monitoring global regulatory developments, guidance, standards, enforcement trends and health authority expectations.
- Assessing the potential impact of regulatory changes on products, technical files, processes, clinical activity and market access.
- Translating complex regulatory developments into clear recommendations, implementation plans and risk-mitigation actions.
- Developing and improving structured regulatory intelligence and surveillance processes.
- Providing strategic regulatory advice to product and project teams throughout the product lifecycle.
- Monitoring competitor activity and wider medical device industry developments.
- Supporting regulatory strategy for new and existing products across international markets.
- Working with authorities including the MHRA, EMA and FDA where appropriate.
- Producing dashboards, metrics and senior-management reports covering emerging risks, opportunities and regulatory trends.
- Establishing and monitoring Regulatory Intelligence KPIs to demonstrate the impact and effectiveness of the function.
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We are particularly interested in speaking with candidates who have substantial experience within the medical device industry and a strong understanding of international regulatory requirements. But if you have strong Regulatory Intelligence Experience in Banking / Finance / Oil & Gas / Aerospace etc then this would be of significant interest as well.
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You are likely to have a degree or equivalent experience within life sciences, engineering, quality or a related discipline, together with strong practical experience of medical device regulatory submissions and approvals.
Experience should ideally include FDA and UK regulatory frameworks, ISO 13485, Quality System Regulations/cGMP, clinical trial requirements for medical devices and technical documentation. The role requires somebody who can interpret complex information, identify the implications for the wider business and communicate recommendations confidently to both technical specialists and senior stakeholders.
Excellent written and spoken English is essential, together with strong presentation, stakeholder-management and analytical skills.
There will be some occasional European and international travel.
This is an excellent opportunity for an experienced regulatory professional to take ownership of regulatory intelligence within a sophisticated global medical device environment and directly influence future regulatory and product strategy.
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