RA Officer

Updated: April 27, 2024 06:13 AM GMT

Morgan Green

Weesp

For one of our clients in the medical devices industry, I'm looking for a driven RA Officer in Flevoland. In this role, you'll act as the link between the quality department and R&D, focusing on regulatory compliance and technical file management. Are you communicative, eager to learn, and flexible? Do you possess knowledge of ISO 13485 and MDR and wish to gain hands-on experience? Then I am looking for you!

Job Description:
• Management of technical files to support product safety and efficacy.
• Responsible for regulatory assessments of changes.
• Design and write summaries for regulatory compliance.
• Provide national and international regulatory support throughout product development, including strategies, planning, change management, and submission documentation.
• Development and maintenance of product dossiers for registrations.
• Provide technical documentation to outsourced suppliers.
• Collaborate with R&D for complaint handling, risk assessments, project and change... More Detail