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Medical Device Regulatory Expert

hace 2 semanas

Cornellà de Llobregat, Barcelona, España beBee Careers A tiempo completo
Regulatory Compliance Specialist

This role is responsible for ensuring regulatory compliance for products marketed by a leading global life sciences company.

The ideal candidate will have experience in international medical device regulatory and quality, with a strong understanding of EU MDR regulations and standards.

Key Responsibilities:

  • Maintain and update Health Authorities databases for Medical Device placing in the market and commercialization.
  • Provide requested documents to subsidiaries and distributors on a case-by-case basis.
  • Participate in external audits and inspections, and perform internal audits.
  • Respond to market requests from customers, subsidiaries, distributors, and other stakeholders.
  • Support Customer Service in providing information to customers.
  • Complete EU MDR Pre-incoming inspections.
  • Prepare documentation required for custom clearance.
  • Assess new or updated regulations and standards applicable to products, and communicate updates to regulatory staff.
  • Prepare, review, approve, distribute, and train on QMS documentation.
  • Support Medicovigilance (FSCA and FSN) for the EU area.

Requirements:

  • University degree in a health or life science related subject.
  • 4 years of practical international medical device regulatory and quality experience.
  • Certified Quality Auditor (CQA) preferred.
  • Fluent in English and Spanish; other languages are a plus.
  • MS Office.

Benefits:

  • Competitive compensation package.
  • Temporary contract until December 31, 2025.
  • Partially remote work option available.
  • Employee Assistance Program (EAP).

This position offers a challenging opportunity to work in an international medical device business with good career prospects. We value diversity and inclusion in the workplace, and all qualified applicants are considered without regard to race, gender, religion, disability, age, or sexual identity.