RA Specialist

Unity Partners exclusively on behalf of our MedTech partner

We are currently looking for a driven RA Specialist eager to advance to RA Manager. In this versatile role, you will play a key part in MDR compliance, obtaining CE marking, preparing for audits, and maintaining relationships with regulatory authorities. You will work closely with the RA/QA team to launch new Medical Devices to the market that significantly impact both human and animal health.

(Part-time is possible)

Key Responsibilities:

• Prepare and submit CE marking dossiers, as well as maintain existing dossiers.
• Optimize the QMS in accordance with ISO 13485 and MDR.
• Coordinate and prepare for internal and external audits.
• Maintain contacts with Notified Bodies and other regulatory authorities.
• Keep updated with regulatory changes.
• Actively contribute to other RA tasks within the company to support the introduction of new products.

Qualifications:

• Bachelor’s or Master’s degree in a relevant field.
• Experience or affinity with technical documentation for Medical Devices.
• At least three years of experience with RA in Medical Devices.
• Extensive knowledge of ISO 13485 and MDD/MDR.
• Independent, enthusiastic, eager to learn, and professional.

Organization & Offer:

You will be part of an innovative and rapidly growing Medical Device organization. This company offers a dynamic workplace where your efforts directly contribute to the development of significant medical devices. Additionally, the organization offers flexible working hours and the possibility of working remotely. You can also expect an attractive salary package.

INTERESTED? For more information or to apply directly, please contact Christian Steenkamp at +31 (0) 20 8938 606 or via christian@unitypartners.nl

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