Hybrid Regulatory Specialist, Medical Devices (MDR/UKCA)

Maclivaro Limited; Mountain Ash; Hybrid; GBP 30,000 - 40,000; Full time

Job summary

A medical device organization is looking for a Regulatory Specialist to join their expanding Regulatory Affairs team. This hybrid role involves managing technical documentation across EU and UK regulations while supporting product development and lifecycle activities. Essential qualifications include a degree in a scientific field and at least 1 year of relevant experience. The successful candidate will gain hands-on experience with regulatory submissions and opportunities for career advancement within a supportive team.

Benefits

Career progression opportunities

Supportive Regulatory team

Hands-on exposure to global activities

Qualifications

• Minimum 1 year of experience in Regulatory Affairs within the medical device industry.
• Ability to work independently and collaboratively within cross-functional teams.
• Strong written and verbal communication skills.

Responsibilities

• Own and maintain product Technical Files and regulatory documentation.
• Generate and maintain key regulatory documents including Risk Management files.
• Support resolution of regulatory-owned quality plans.

Skills

EU MDR knowledge

UK MDR knowledge

ISO 13485

ISO 14971

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Adobe tools

Education

Degree in scientific or engineering discipline

Job description

A medical device organization is looking for a Regulatory Specialist to join their expanding Regulatory Affairs team. This hybrid role involves managing technical documentation across EU and UK regulations while supporting product development and lifecycle activities. Essential qualifications include a degree in a scientific field and at least 1 year of relevant experience. The successful candidate will gain hands-on experience with regulatory submissions and opportunities for career advancement within a supportive team.