Remote Quality & Regulatory Specialist – Medical Device Software

Vero HR Limited; Cambridge; Remote; GBP 45,000 - 55,000; Full time

Benefits offered by this job

28 days annual leave

Birthday day off

Fully remote with quarterly in-person팀

Vitality Healthcare

Life Assurance (4x salary)

Training & Development

Job summary

Vero HR Limited is seeking a Quality & Regulatory Specialist to join our client’s Medical Device and International Standards team. The role focuses on software-driven medical devices, guiding regulatory documentation and quality foundations for market entry.

You will work with engineers, product teams, and leadership to translate complex requirements into practical solutions while maintaining high standards of quality assurance and regulatory compliance.

Qualifications

• Experience in software-based medical devices and related regulatory environments.
• Experience in medical device quality management systems.
• Ability to guide engineers and shape documentation alongside development teams.
• Strong understanding of quality and regulatory expectations for medical devices.

Responsibilities

• Deliver quality and regulatory client projects focused on medical devices with software elements.
• Educate clients on why regulatory documentation is needed, not just what is required.
• Create, review, and structure medical device technical documentation.
• Support quality and design activities aligned to medical device regulations and standards.
• Help clients compile and organise documentation into regulator-ready formats.
• Adapt internal templates to meet client and product needs.
• Lead client meetings and guide discussions with clarity and confidence.
• Collaborate with software engineers, product teams, HR, and senior stakeholders.
• Deliver multiple client projects in a consulting environment.

Skills

Software in medical devices

Quality management

Regulatory knowledge

Stakeholder communication

Organisational skills

Independent work

Job description

Vero HR Limited is seeking a Quality & Regulatory Specialist to join our client’s Medical Device and International Standards team. The role focuses on software-driven medical devices, guiding regulatory documentation and quality foundations for market entry.

You will work with engineers, product teams, and leadership to translate complex requirements into practical solutions while maintaining high standards of quality assurance and regulatory compliance.