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Regulatory Compliance Expert for Medical Device Innovation

hace 2 meses


Gasteiz Vitoria, Álava, España Merlin Digital Partner A tiempo completo

Merlin Digital Partner, a leading talent acquisition consultancy with over 20 years of experience in the digital world, is seeking a highly skilled Regulatory Compliance Specialist to join its team.

As a key member of our team, you will play a critical role in ensuring the company's medical device products comply with the European Union's Medical Device Regulation (MDR) 2017/745 and ISO 13485 standards. Your expertise will be instrumental in maintaining the company's commitment to regulatory compliance and product safety.

Key Responsibilities:
  • Oversight of regulatory compliance of all medical devices, ensuring conformity with MDR and ISO 13485
  • Liaising with Notified Bodies and Competent Authorities for regulatory matters
  • Ensuring technical documentation and EU Declarations of Conformity are up-to-date and compliant
  • Supervising post-market surveillance and vigilance activities, ensuring timely reporting of incidents
  • Maintaining an in-depth understanding of global medical device regulations and standards

You will work closely with various departments to ensure regulatory considerations are integrated into the product lifecycle. This includes collaborating with D&D, Quality Assurance, and other teams to guarantee that regulatory requirements are met throughout the development process.

To succeed in this role, you will need a strong analytical and strategic thinking ability, excellent communication skills, and a thorough understanding of regulatory frameworks such as MDR 2017/745 and ISO 13485. A bachelor's or master's degree in life sciences, engineering, legal, or a related field is required, along with at least two years of experience in regulatory affairs within the medical device industry.

We offer a dynamic, innovative work environment where creativity and new ideas are encouraged. You will have opportunities for professional growth and career advancement, and we provide flexible working arrangements to support your needs.

Estimated salary: €70,000 - €90,000 per year, depending on experience and qualifications.