Job Description: Senior Regualtory Manager
Role Overview
We are seeking a hands-on Senior regulatory Manager to take ownership of product compliance, quality systems, and regulatory documentation across a growing product portfolio. This role is responsible for managing technical files, ensuring compliance with UK, EU, and US regulations, and maintaining effective quality and environmental management systems.
This is a key role within the business, offering the opportunity to lead the compliance function and play a central part in preparing the organisation for ISO 13485 certification.
Key Responsibilities
Product Compliance & Documentation
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Own and manage Product Technical Files across the full product range
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Ensure products meet UKCA, CE, MHRA, FDA, and applicable US labelling and regulatory requirements
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Create, review, and maintain Instructions for Use (IFUs) in line with regulatory standards
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Maintain accurate and up-to-date compliance documentation
Quality & Environmental Management Systems
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Operate, maintain, and continuously improve the ISO 9001 Quality Management System
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Manage and support the ISO 14001 Environmental Management System
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Ensure quality processes remain effective, compliant, and audit-ready
Testing & Standards
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Create and manage product testing schedules
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Ensure products meet internal specifications and external regulatory requirements
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Coordinate testing activities and manage records of results and approvals
Regulatory & Certification Readiness
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Lead the scoping and preparation activities for ISO 13485 certification
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Identify gaps, implement improvements, and support readiness for external audits
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Monitor regulatory changes and assess impact on products and systems
Skills & Experience
Essential:
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Proven experience in a Quality, Compliance, or Regulatory role
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Strong working knowledge of UKCA and CE marking
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Experience working with ISO 9001 and ISO 14001 management systems
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Experience managing technical documentation and product compliance files
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Confident working with regulatory standards and audits
Desirable:
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Experience with MHRA and FDA regulations
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Experience preparing for or working towards ISO 13485
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Background in medical devices, healthcare products, or other regulated manufacturing environments
Personal Attributes
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Hands-on and detail-oriented approach
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Strong organisational and documentation skills
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Able to work independently and take full ownership of the compliance function
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Clear communicator with internal and external stakeholders
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Comfortable working in a growing, evolving business environment
Employment Details & Benefits
Salary: £60K - 80K (dependent on experience)
Bonus: Profit share scheme
Holiday: 23 days annual leave plus 8 bank holidays
Additional leave: Bonus birthday holiday
Benefits: Optional private healthcare scheme
Working pattern: Full-time, 8:00am – 4:30pm
Location: Hybrid
Why Apply?
This is an opportunity to take ownership of compliance within a growing business, shape the next phase of quality and regulatory systems, and play a pivotal role in achieving future certification milestones