SaMD Regulatory Lead — EU MDR & Global Compliance

Docplanner; Barcelona; À distance; EUR 50 000 - 70 000; Plein temps

Avantages offerts par ce poste

Healthcare insurance

Wellness programs

Flexible time off

Employee Share Option Plan

Résumé du poste

A leading healthcare platform in Barcelona seeks a Senior Healthcare Regulatory Specialist to ensure compliance with EU Medical Device Regulation (MDR) while driving global expansion. The role involves collaborating across teams to develop a robust regulatory framework, facilitating market access for innovative healthtech products. Ideal candidates have strong regulatory knowledge, project management experience, and excellent communication skills. This position supports remote work flexibility, offering competitive global benefits and opportunities for professional growth.

Qualifications

• Strong knowledge of EU Medical Device Regulation (MDR), particularly in a Software as a Medical Device (SaMD) context.
• Practical experience in medical device regulatory affairs and solid understanding of Quality Management Systems (QMS).
• Ability to manage cross-functional regulatory projects independently.

Responsabilités

• Achieve mandatory Medical Device Regulation certification to maintain European market access.
• Lead MDR certification and other accreditation processes across target jurisdictions.
• Build robust governance systems that stakeholders can trust.

Connaissances

Strong knowledge of EU Medical Device Regulation (MDR)

Practical experience in medical device regulatory affairs

Relevant academic background in law, medicine, pharmacy, engineering, or scientific field

Experience with EUDAMED and CAPA systems

Strong communication skills

Fluency in English and Spanish or other EU languages

Formation

Degree in law, medicine, pharmacy, engineering or scientific field

Description du poste

A leading healthcare platform in Barcelona seeks a Senior Healthcare Regulatory Specialist to ensure compliance with EU Medical Device Regulation (MDR) while driving global expansion. The role involves collaborating across teams to develop a robust regulatory framework, facilitating market access for innovative healthtech products. Ideal candidates have strong regulatory knowledge, project management experience, and excellent communication skills. This position supports remote work flexibility, offering competitive global benefits and opportunities for professional growth.