Global Regulatory Affairs Manager - Medical Devices

Vicon Motion Systems Limited; United Kingdom; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading technology company in the UK seeks a Regulatory Affairs Manager to oversee regulatory clearances in global markets. This role requires 5+ years of compliance experience and a strong understanding of regulatory requirements for medical devices. The successful candidate will manage submissions, interact with authorities, and prepare technical documentation. Offers competitive salary and benefits including pension and private medical insurance.

Benefits

Competitive salary

10% Company Pension

25 days Annual Leave + Bank Holidays

Life Cover

Private Medical with Optical / Dental Insurance

Permanent Health Insurance

Cycle to work scheme

Free On-site Parking

Qualifications

• 5+ years of experience in a compliance role.
• Strong understanding of applicable regulatory requirements.

Responsibilities

• Manage regulatory clearances in global markets.
• Plan medical device regulatory submission activities.
• Interact with authorities for license applications.

Skills

Experience with EU MDR transition

Understanding of EU MDD and EU MDR transition

Knowledge of US medical device legislation

Familiarity with electromechanical medical devices

Proficient in MS Office applications

Exceptional written and verbal communication skills

Job description

A leading technology company in the UK seeks a Regulatory Affairs Manager to oversee regulatory clearances in global markets. This role requires 5+ years of compliance experience and a strong understanding of regulatory requirements for medical devices. The successful candidate will manage submissions, interact with authorities, and prepare technical documentation. Offers competitive salary and benefits including pension and private medical insurance.