Compliance and Design Manager

TN United Kingdom; Ilminster; On-site; GBP 50,000; Full time

Job summary

An established industry player in medical device design and manufacturing is seeking a Compliance and Design Manager to ensure regulatory compliance and oversee product design. This role involves working with mobility devices, maintaining technical documentation, and ensuring adherence to UK and EU regulations. The ideal candidate will have experience in regulatory compliance, knowledge of ISO standards, and a passion for innovative product design. Join a dynamic team in Somerset and contribute to the development of safe and effective mobility solutions that enhance lives.

Qualifications

• Minimum 1 year in regulatory compliance for medical devices.
• Knowledge of UK MDR 2002 and EU MDR (2017/745).

Responsibilities

• Ensure ongoing regulatory compliance for medical devices.
• Oversee product compliance and technical documentation.

Skills

Technical Manager

Compliance Manager

Design Manager

UKPR

PRRC

Regulatory Compliance

ISO 13485

Education

Degree in Life Sciences

Degree in Engineering

Degree in Law

Degree in Medicine

Job description

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.