Senior Regulatory Affairs Specialist, Medical Devices UK/CE

Medtronic plc; Greater London; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A global health technology company is seeking a Principal Regulatory Affairs Specialist in London. This hybrid role involves ensuring regulatory compliance for medical devices, including submissions to UK MHRA and CE/UKCA marking. The ideal candidate should have substantial experience in medical device regulations, excellent technical writing skills, and the ability to interact effectively with regulatory authorities. This position offers a competitive salary and a commitment to employee development.

Benefits

Competitive salary

Flexible benefits package

Short-term incentive plan

Qualifications

• Experience with UK MHRA submissions and CE/UKCA marking.
• Strong knowledge of ISO 13485 and ISO 14971 principles.
• Ability to interact effectively with regulatory authorities.

Responsibilities

• Coordinate document packages for regulatory submissions.
• Lead preparation of submissions and license renewals.
• Advise on compliance changes regarding labelling and protocols.

Skills

Experience in medical device regulatory

Knowledge of EU MDR

Technical writing skills

Job description

A global health technology company is seeking a Principal Regulatory Affairs Specialist in London. This hybrid role involves ensuring regulatory compliance for medical devices, including submissions to UK MHRA and CE/UKCA marking. The ideal candidate should have substantial experience in medical device regulations, excellent technical writing skills, and the ability to interact effectively with regulatory authorities. This position offers a competitive salary and a commitment to employee development.