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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.