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
Own and manage Product Technical Files across the full product range
Ensure products meet UKCA, CE, MHRA, FDA, and applicable US labelling and regulatory requirements
Create, review, and maintain Instructions for Use (IFUs) in line with regulatory standards
Maintain accurate and up-to-date compliance documentation
Quality & Environmental Management Systems
Operate, maintain, and continuously improve the ISO 9001 Quality Management System
Manage and support the ISO 14001 Environmental Management System
Ensure quality processes remain effective, compliant, and audit-ready
Testing & Standards
Create and manage product testing schedules
Ensure products meet internal specifications and external regulatory requirements
Coordinate testing activities and manage records of results and approvals
Regulatory & Certification Readiness
Lead the scoping and preparation activities for ISO 13485 certification
Identify gaps, implement improvements, and support readiness for external audits
Monitor regulatory changes and assess impact on products and systems
Skills & Experience
Essential:
Proven experience in a Quality, Compliance, or Regulatory role
Strong working knowledge of UKCA and CE marking
Experience working with ISO 9001 and ISO 14001 management systems
Experience managing technical documentation and product compliance files
Confident working with regulatory standards and audits
Desirable:
Experience with MHRA and FDA regulations
Experience preparing for or working towards ISO 13485
Background in medical devices, healthcare products, or other regulated manufacturing environments
Personal Attributes
Hands-on and detail-oriented approach
Strong organisational and documentation skills
Able to work independently and take full ownership of the compliance function
Clear communicator with internal and external stakeholders
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.
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