Regulatory Affairs Officer

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. We are recruiting a Regulatory Affairs Officer to join the Regulatory Affairs team based near Edinburgh. The role is responsible for building regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements, and managing product license registration with regulatory authorities worldwide.

Requirements

• A relevant degree and/or relevant work experience in a regulatory affairs environment.
• Experience in medical device/IVD/Biotech industry
• Experienced in meeting with, making presentations to, and negotiating with regulators
• Previous experience preparing and submitting BLA, 510(k), PMA, CE mark and technical files to other worldwide regulatory authorities.

Benefits

• Flexible working environment
• Range of core and flexible benefits
• Pension
• Private medical cover
• Life assurance
• Additional annual leave
• Cycle to work
• Technology
• Experience days
• Access to marketplace discounts