Below is a refined version of the job description for better clarity, formatting, and focus:
Compliance and Design Manager, Ilminster
Client: System Recruitment Limited
Location: Ilminster, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: 76d387272687
Job Views: 10
Posted: 26.04.2025
Expiry Date: 10.06.2025
Job Description
We are a leading designer and manufacturer of medical devices, including mobility scooters, chairs, and beds. We have an immediate requirement for a Technical Manager with Compliance and Design experience to join our team at our offices in Somerset.
Key Skills
* Technical Manager, Compliance Manager, Design Manager
* UKPR, PRRC, Regulatory Compliance
* ISO 13485
Location
Ilminster, with commuting options from Taunton, Yeovil, Chard, Bridgwater, and surrounding areas – TA19 9AR
Salary
Circa £50,000 plus benefits
Main Responsibilities
* Ensure ongoing regulatory compliance and design across UK and EU markets for medical devices.
* Oversee product compliance, technical documentation, post-market surveillance, and regulatory liaison.
* Support the safe and effective placement of mobility scooters, power chairs, and related products on the market.
Qualifications & Experience
* Minimum 1 year of professional experience in regulatory compliance for medical devices (EU MDR PRRC requirements).
* Knowledge of UK MDR 2002 and EU MDR (2017/745).
* Experience managing device registrations with MHRA and liaising with EU Notified Bodies.
* Understanding of ISO 13485, ISO 7176, and applicable standards.
Desirable
* Degree in Life Sciences, Engineering, Law, Medicine, or related fields.
* Experience with mobility devices.
* Familiarity with FDA and Health Canada regulations.
Key Skills
* Regulatory frameworks and compliance management.
* Interpreting complex regulatory requirements.
* Documentation, project management, and communication skills.
* Attention to quality and safety.
* Cross-functional collaboration.
Key Responsibilities
* Ensure devices comply with UK MDR 2002 and EU regulations.
* Maintain technical documentation and declarations of conformity.
* Register devices with MHRA and manage product registrations.
* Coordinate with MHRA, handle incident reporting, vigilance, and recalls.
* Manage UKCA marking processes.
* Conduct post-market surveillance.
* Support audits and inspections.
Product Design Responsibilities
* Lead and support the design of new mobility products.
* Collaborate with teams to incorporate customer insights into safe, innovative designs.
* Ensure designs meet safety standards like ISO 7176, ISO 13485.
* Participate in development, prototyping, and testing.
* Work with suppliers to meet design specifications.
* Document design controls, risk assessments, and usability testing.
* Drive continuous product improvement and innovation.
General Responsibilities
* Serve as the internal expert for UK and EU medical device regulations.
* Integrate regulatory considerations into product development and lifecycle management.
* Stay updated on evolving regulations and proactively manage compliance.
* Maintain technical files, risk assessments, and clinical evaluations.
This role is suitable for a technical, design, or compliance manager based in Somerset or willing to relocate.
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