Regulatory Affairs Specialist

Currently, I’m looking for a RA Specialist to join a leading European Medical Device manufacturer. As a member of the RA/QA team, you will play a key role in ensuring the safety and effectiveness of their products, which are used by healthcare professionals across Europe.

 

MAIN RESPONSIBILITIES

• Collaborate with Product Management to develop regulatory strategies and drive new product development
• Collect, register, maintain, and distribute technical files for private label products in compliance with applicable laws and regulations
• Review and update technical files for self-certification and certification in cooperation with a Notified Body
• Monitor external changes to related standards and assess their impact on the company
• Provide QA/RA guidance and information to internal stakeholders
• Maintain relationships with clients and suppliers regarding quality and regulatory aspects

 

YOUR PROFILE

• Bachelor’s degree in a scientific or technical discipline, preferably with a biomedical or pharmaceutical background
• At least 2 years of experience in regulatory affairs for medical devices, with knowledge of MDR, ISO 13485, ISO 14971, ISO 10993, and quality systems
• Experience with technical file preparation and maintenance
• Familiarity with vigilance, monitoring, and complaint handling during the product life cycle

 

ORGANISATION AND OFFER

If you are a talented professional with a passion for ensuring patient safety and want to work in a dynamic, international team, this is the right match. Join the company in its mission to improve patients' lives across Europe while advancing your career in the regulatory environment.

The company offers a competitive salary and benefits. Besides that, there are a lot of opportunities for personal development and career progression.

 

INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or c.steenkamp@panda-int.com