Regulatory Affairs Officer

AliveDx, a leading player in in-vitro diagnostics, is seeking a Regulatory Affairs Officer to support the company's regulatory strategy and product licensing with regulatory authorities worldwide. This role involves advising staff, preparing documentation, coordinating submissions, and ensuring compliance with international regulations such as ISO 13485, IVD Directive 98/79/EC, and FDA guidelines.

Requirements

• Advise AliveDx staff and project team members on data and information for license applications
• Prepare and compile regulatory documentation and coordinate submission for various countries (US, EU, Canada, etc.)
• Develop product labelling and ensure compliance with regulatory requirements
• Maintain product regulatory documents and technical files
• Liaise with regulatory authorities and coordinate interpretation of information

Benefits

• Pension
• Private medical cover
• Life assurance
• Additional annual leave
• Cycle to work
• Technology
• Experience days
• Access to marketplace discounts