Beschrijving

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 we are 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 management, CAPA management, and internal audits.

Profile:

• Bachelor's degree in a relevant field.
• Experience in the medical devices, pharmaceutical, or biotech industry.
• Knowledge of MDR, ISO 13485, and technical files.
• Strong communication skills, out-of-the-box thinking, and eagerness to learn.

Company:
Our client specializes in medical aesthetics and has ambitious goals to become the dominant player in their market globally. You'll join a team of 8 (quality & regulatory), where learning and developing together is key. It's a growing organisation, where people are very ambitious and friendly. 

Offer:

• Market-competitive salary
• 13th-month payment.
• Room for personal development.
• 40 hours per week, negotiable.

Apply Now!
Interested or have questions about this vacancy? Contact Marre Raddatz via m.raddatz@morgangreen.nl or call +31 (0)30 200 3408.