Regulatory Specialist – Medical Devices (NPD & MDR, Global)

BioTalent; Reading; On-site; GBP 42,000 - 63,000; Full time

Job summary

BioTalent is partnering with a SME Class 2 Device business in Reading to recruit a Regulatory Affairs professional. The role offers exposure to both new product development and introductions, with guidance from an experienced leader and a broad range of tasks.

The successful candidate will have at least 3 years in regulatory affairs for Medical Devices or IVD, hands-on ISO 13485 experience, and familiarity with MDR updates, technical files, and registrations.

Qualifications

• Minimum 3 years in regulatory affairs within Medical Devices or IVD.
• Experience with ISO 13485 compliance.
• Hands-on with technical file creation, MDR updates, and registrations.

Responsibilities

• Contribute across NPD and NPI regulatory activities.
• Support lifecycle regulatory tasks under senior leadership.
• Handle a range of regulatory tasks with varied scope.

Skills

Regulatory affairs

Medical devices

MDR updates

Global market exposure

Job description

BioTalent is partnering with a SME Class 2 Device business in Reading to recruit a Regulatory Affairs professional. The role offers exposure to both new product development and introductions, with guidance from an experienced leader and a broad range of tasks.

The successful candidate will have at least 3 years in regulatory affairs for Medical Devices or IVD, hands-on ISO 13485 experience, and familiarity with MDR updates, technical files, and registrations.