Global Regulatory Affairs Specialist - Medical Devices

Cedent Consulting; Bedford; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A life sciences consultancy in Bedford, UK, is seeking a Regulatory Affairs Specialist to determine and document change assessments for US and EU medical devices. The ideal candidate will have a Bachelor's degree, at least 3 years of experience in the medical device field, and strong communication skills. This role requires knowledge of regulatory submissions and the ability to work independently in a hybrid setting.

Qualifications

• 3+ years of experience in the medical device field.
• Experience with regulatory submissions to medical device authorities.
• Strong knowledge of US and international regulatory requirements.

Responsibilities

• Determine and document change assessments for US Class II devices.
• Plan and prepare submissions for EU Class III & IIb devices.
• Support submission and maintenance of product registrations.

Skills

Excellent written and verbal communication skills

Analytical skills

Interpersonal skills

Time management

Education

Bachelor’s degree in life sciences

Job description

A life sciences consultancy in Bedford, UK, is seeking a Regulatory Affairs Specialist to determine and document change assessments for US and EU medical devices. The ideal candidate will have a Bachelor's degree, at least 3 years of experience in the medical device field, and strong communication skills. This role requires knowledge of regulatory submissions and the ability to work independently in a hybrid setting.