Senior Regulatory Affairs Lead - Medical Devices

Scienceabode; City of Edinburgh; On-site; GBP 50,000; Full time

Job summary

A leading medical device manufacturer in the Edinburgh area is looking for a Senior Regulatory Affairs Officer. You will manage product licence registrations and collaborate with international regulatory bodies. The ideal candidate has significant experience in the medical device sector, particularly with IVDs, and expertise in CE and FDA regulations. This role offers a competitive salary of £50,000 per annum and numerous opportunities for professional development within a multinational team.

Benefits

Competitive base salary

Opportunities for personal development

Qualifications

• Prior experience in a regulatory role, ideally in an FDA licensed manufacturing facility.
• Significant experience within the medical device sector is essential.
• Expert-level knowledge of CE and FDA regulations, including PMA, BLA, and 510(k).

Responsibilities

• Manage and deliver product licence registration.
• Help build the company's regulatory strategy and ensure compliance.
• Prepare regulatory documentation and submit across US, UK, and EU.

Skills

Regulatory role experience

Excellent communication skills

Knowledge of CE and FDA regulations

Job description

A leading medical device manufacturer in the Edinburgh area is looking for a Senior Regulatory Affairs Officer. You will manage product licence registrations and collaborate with international regulatory bodies. The ideal candidate has significant experience in the medical device sector, particularly with IVDs, and expertise in CE and FDA regulations. This role offers a competitive salary of £50,000 per annum and numerous opportunities for professional development within a multinational team.