Global Regulatory Affairs Lead – Medical Devices

Vicon; Yarnton; On-site; GBP 60,000 - 75,000; Full time

Benefits offered by this job

Competitive salary

10% Company Pension

25 days Annual Leave

Private Medical Insurance

Cycle to work scheme

Free On-site Parking

Job summary

A leading technology firm in the United Kingdom is seeking a Regulatory Affairs Manager to oversee regulatory clearances in global markets. The ideal candidate will have over 5 years of compliance experience in the medical device sector and a strong knowledge of EU and FDA regulations. This role offers an opportunity to contribute directly to the regulatory strategy and ensure compliance across products in a cutting-edge technology environment.

Qualifications

• 5+ years in a compliance role required.
• Experience with EU MDR transition and technical submissions.
• Familiarity with software-based medical devices is a plus.

Responsibilities

• Manage regulatory clearances for global markets.
• Plan and execute medical device submission activities.
• Act as ambassador for the company with authorities.

Skills

Regulatory compliance experience

Strong communication skills

Understanding EU MDR and FDA regulations

Experience with medical devices

Proficient use of MS Office

Job description

A leading technology firm in the United Kingdom is seeking a Regulatory Affairs Manager to oversee regulatory clearances in global markets. The ideal candidate will have over 5 years of compliance experience in the medical device sector and a strong knowledge of EU and FDA regulations. This role offers an opportunity to contribute directly to the regulatory strategy and ensure compliance across products in a cutting-edge technology environment.