Senior Regulatory Affairs Specialist - Global MedTech EU

BD (Becton, Dickinson and Co.); Almaraz; Presencial; EUR 38.000 - 60.000; Jornada completa

Descripción de la vacante

BD (Becton, Dickinson and Company) is seeking a Senior Regulatory Affairs Specialist at the Sendal Almaraz facility in Spain. You will provide regulatory expertise across the IPD portfolio and lead submissions for Class I and II devices.

The role reports to the Senior Manager, Regulatory Affairs and involves global market access and ongoing compliance. The successful candidate will work with Quality, R&D, Medical Affairs, Marketing and other teams to integrate regulatory requirements into

Formación

• Bachelor’s degree in regulatory-related field is required.
• 3–5 years regulatory affairs experience in medical devices.
• Knowledge of EU MDR, UK MDR and US FDA requirements.
• Experience with ISO 13485 QMS and regulatory submissions.

Responsabilidades

• Support regulatory submissions and product registrations for global markets.
• Provide regulatory guidance across projects and review design/documentation.
• Develop and maintain regulatory procedures and processes.
• Collaborate with Quality, R&D, Medical Affairs, and Marketing.
• Interpret regulatory requirements and communicate to cross-functional teams.
• Identify regulatory risks and propose mitigation strategies.
• Support customer inquiries and tender responses as needed.
• Contribute to post-market surveillance and lifecycle activities.
• Assist with change control and sustaining engineering initiatives.

Conocimientos

Regulatory affairs

Medical devices

EU MDR

FDA requirements

ISO 13485

Technical documentation

Change control

Cross-functional collaboration

Project management

Analytical skills

Communication skills

Educación

Bachelor's degree in Regulatory Science, Biomedical Engineering, Pharmaceutical Sciences, Life Sciences, or related scientific discipline

Descripción del empleo

BD (Becton, Dickinson and Company) is seeking a Senior Regulatory Affairs Specialist at the Sendal Almaraz facility in Spain. You will provide regulatory expertise across the IPD portfolio and lead submissions for Class I and II devices.

The role reports to the Senior Manager, Regulatory Affairs and involves global market access and ongoing compliance. The successful candidate will work with Quality, R&D, Medical Affairs, Marketing and other teams to integrate regulatory requirements into