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Regulatory Compliance Expert for Medical Devices
hace 2 meses
**About Merlin Digital Partner**
We are a leading IT and Digital headhunting company with over a decade of experience. Our mission is to revolutionize companies by seamlessly integrating top-tier talent. We partner with industry heavyweights such as Wallapop, Glovo, Banc Sabadell, and Factorial.
**Job Overview**
We are currently looking for a Specialist Regulatory Compliance (PRRC) expert to join our team. The role involves ensuring the company's medical device products comply with the European Union's Medical Device Regulation (MDR) 2017/745 and ISO 13485 standards.
**Responsibilities**
- Oversee regulatory compliance of all medical devices, ensuring conformity with MDR and ISO 13485.
- Liaise with Notified Bodies and Competent Authorities for regulatory matters.
- Ensure technical documentation and EU Declarations of Conformity are up-to-date and compliant.
- Supervise post-market surveillance and vigilance activities, ensuring timely reporting of incidents.
- Maintain an in-depth understanding of global medical device regulations and standards.
**Requirements**
- Bachelor's or Master's degree in life sciences, engineering, legal, or another relevant field.
- At least 2 years of experience in regulatory affairs within the medical device industry.
- Detailed knowledge of MDR 2017/745, ISO 13485, and related regulatory frameworks.
**Compensation**
The estimated salary for this position is around **€80,000 - €110,000 per year**, depending on location and experience.
