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