RA & QA - Medical Devices (Medical Software)

• Experience in working in a quality department ISO 13485
• Good understanding of regulatory requirements such as the US FDA and CE marking

A medical imaging software development company

Position description

The regulatory affairs specialist will collaborate with various departments to ensure that all product development complies with all regulatory and safety requirements. Responsible for the day-to-day monitoring of the company's regulatory activities to ensure compliance with all regulations. Prepare and submit all regulatory dossiers for the regulatory agencies.

Ensure a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.

Document internal regulatory processes such as internal audits, inspections, licence renewals and/or registrations. Main responsibilities

• Ensure that the company's products comply with the regulations of the regions they want to distribute in.


• Keep up to date with national and international legislation, guidelines and customer practices. Evaluate applicable laws and regulations to determine impact on company activities.


• Ensure accurate timely submissions to regulatory agencies.


• Assist with the preparation and submissions of all regulatory reports. Prepare submissions of licence variations and renewals to strict deadlines.


• Proactively collaborate with the Quality Assurance team to meet product regulatory requirements, including data generation and completion of required dossiers for product approval.


• Train company staff in matters related to regulatory affairs.

Career and professional development opportunities

• Minimum of a Bachelor's Degree in a scientific field such as Biochemistry, Chemistry, Pharmacy or Molecular Biology or engineering, computer science, bioengineering.


• 2 years' experience in working in a quality department ISO 13485.


• Excellent written and verbal communication skills, with the ability to effectively communicate regulatory information in English.


• Experience in the submission and compilation of regulatory dossiers to European and international agencies.


• Experience in dealing with the AEMPS and other agencies (MHRA, FDA, .).


• Good understanding of regulatory requirements and current industry practices such as the US FDA and CE marking (MDR).


• Knowledge of standards relating to products and quality systems (ISO 9001 / ISO 13485).