Senior Regulatory Manager

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