Compliance and Design Manager

A leading designer and manufacturer of medical devices including mobility scooters, chairs and beds have an immediate requirement for a Technical Manager with Compliance and design experience to join them at their offices in Somerset.

Key Skills: Technical Manager, compliance manager, design manager, UKPR, PRRC, Regulatory Compliance, ISO 13485,

Location: Ilminster, commutable from Taunton, Yeovil, Chard, Bridgwater, Martock, Langport, Wellington, Crewkerne, Glastonbury, Lyme Regis, Honiton, Axminster, Cullompton, Tiverton - TA19 9AR

Salary: Circa 50,000 + benefits

As compliance / design / technical manager your main role will be to ensure ongoing regulatory compliance and design across both UK and EU markets for medical device products. Overseeing product compliance, technical documentation, post-market surveillance, and regulatory liaison, ensuring safe and effective mobility scooters, power chairs, and related products are placed on the market.

Qualifications & Experience:

• Minimum of 1 year of professional experience in regulatory compliance for medical devices (per EU MDR PRRC requirements).
• Demonstrable knowledge of UK MDR 2002 and EU MDR (2017/745).
• Experience managing device registrations with the MHRA and liaising with EU Notified Bodies.
• Strong understanding of ISO 13485, ISO 7176 (wheelchairs and scooters), and applicable standards.

Desirable:

• Degree in Life Sciences, Engineering, Law, Medicine, or related fields.
• Hands-on experience with mobility devices (scooters, power chairs, rehabilitation equipment).
• Familiarity with global medical device regulations (FDA, Health Canada) is a plus.

Key Skills:

• Detailed understanding of regulatory frameworks and compliance management.
• Ability to interpret and apply complex regulatory requirements in practical settings.
• Excellent documentation, project management, and communication skills.
• Analytical, with a strong focus on quality and safety.
• Capable of working cross-functionally between design, quality, and commercial teams.

Key Responsibilities:

• Ensure all devices placed on the UK market comply with UK MDR 2002.
• Verify that Technical Documentation and Declarations of Conformity are complete and up to date.
• Register devices with the MHRA and maintain accurate product registrations.
• Facilitate communication with the MHRA and support incident reporting, vigilance activities, and recalls if necessary.
• Oversee and maintain UKCA marking processes.
• Ensure post-market surveillance is conducted according to regulatory requirements.
• Support audits and inspections from regulatory authorities and Notified Bodies.

Product Design Responsibilities:

• Lead and contribute to the design and development of new mobility products, including mobility scooters, power chairs, and associated components.
• Collaborate with cross-functional teams to capture customer insights and translate them into innovative, safe, and market-leading product designs.
• Ensure that product designs comply with relevant safety standards such as ISO 7176, ISO 13485, and other applicable regulations.
• Participate in concept development, prototyping, and testing phases to validate design performance and safety.
• Work closely with suppliers and manufacturing teams to ensure that design specifications are met throughout production.
• Support the documentation of design controls, risk assessments, and usability testing in compliance with medical device regulations.
• Drive continuous improvement and next-generation product innovation based on emerging technologies, materials, and user needs.

General Responsibilities:

• Serve as the internal expert for UK and EU medical device regulatory affairs.
• Work closely with product design, quality, and operations teams to ensure regulatory considerations are embedded in product development and lifecycle management.
• Keep up to date with evolving regulations in both the UK and EU and proactively manage compliance strategies.
• Support the creation and maintenance of technical files, risk assessments, and clinical evaluations.

This role would suit a technical manager, design manager, compliance manager who is located in Somerset or free to relocate.