Medical Device Usability jobs

Position Overview

We are seeking a dedicated and experienced Regulatory and Compliance Manager to lead and maintain our company’s regulatory compliance framework across key standards and bodies, including ISO 13485, DAMAS, and the MHRA. As a medical device manufacturer, we require an individual who has proven experience in a similar role, preferably with knowledge of ISO 13485.

This is a pivotal role responsible for embedding compliance into the heart of our operations, contributing directly to system development, quality control, customer experience, and business integrity.

The successful candidate will also ensure compliance with medical device manufacturing requirements, particularly in relation to our Lab-to-Lab services model, where we act as both a manufacturer and supplier within the clinical and dental ecosystem.

They will additionally lead initiatives in cybersecurity compliance aligned with ISO 27001, and manage our intellectual property portfolio including patents, trademarks, and product licensing.

Key Responsibilities

Regulatory Compliance – Medical Devices & Lab-to-Lab Services

• Maintain and develop full regulatory compliance for medical device manufacturing under ISO 13485 and MHRA guidelines.
• Ensure robust implementation of post-market surveillance, risk management, and product traceability processes.
• Ensure DAMAS compliance specific to dental laboratory practices and quality systems.
• Develop and manage documentation and procedures to support regulatory requirements across our Lab-to-Lab service model.
• Coordinate internal and external audits, ensuring readiness at all times.

Quality & Systems Development

• Collaborate cross-functionally with R&D, Operations, Sales, and Customer Support to embed compliance and quality assurance into business processes.
• Support continuous improvement initiatives that enhance system efficiency and customer satisfaction.
• Lead CAPA and internal review systems in collaboration with the wider team.

Cybersecurity & Data Compliance

• Lead the implementation and management of cybersecurity compliance aligned with ISO 27001.
• Ensure alignment between digital systems, data protection protocols, and regulatory expectations for medical devices and patient-related data.

Intellectual Property & Legal Compliance

• Manage and organise compliance around IP assets: patents, trademarks, and product licences.
• Liaise with legal and R&D teams to ensure accurate registration, renewal, and protection of proprietary technologies and services.

Pay: £32,000.00-£50,000.00 per year

Ability to commute/relocate:

• Enniskillen BT94 1RL: reliably commute or plan to relocate before starting work (required)

Application question(s):

• Do you have experience in a regulatory or compliance role?

Experience:

• ISO 13485: 1 year (preferred)

Work Location: In person