Overview
Senior Regulatory Manager Jobs in Hull, UK at Identify Talent
Position: Senior Regulatory Manager (Permanent)
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 ISOcertification.
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 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 ISOcertification
* 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 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
Title: Senior Regulatory Manager
Company: Identify Talent
Location: Hull, UK
Category:
