Senior Regulatory Affairs Specialist - Medical Devices (1 Year)

Eag (Empresarios Agrupados - Ghesa); Cáceres; On-site; EUR 38,000 - 60,000; Full time

Job summary

Becton, Dickinson, and Company (BD) is seeking a Senior Regulatory Affairs Specialist to provide regulatory expertise for IPD portfolio at our Sendal Almaraz, Spain facility. You will support global regulatory activities for Class I to II/IIa devices, ensuring compliant documentation and successful market access.

In collaboration with Quality, R&D, Medical Affairs, and Marketing, you will prepare submissions, interpret EU MDR, FDA and international requirements, and guide project teams toward

Qualifications

• Bachelor's degree in Regulatory Science, Biomedical Engineering, Pharmaceutical Sciences, Life Sciences, or related field.
• Approximately 3–5 years of Regulatory Affairs experience in medical devices.

Responsibilities

• Support regulatory submissions and registrations to meet market access in global markets.
• Prepare, maintain, and update technical documentation and regulatory submissions.
• Interpret and communicate EU MDR, FDA, ISO standards and other regulations to cross‑functional teams.
• Identify regulatory risks and provide mitigation strategies to project teams and management.
• Contribute to product development projects and change control activities to ensure compliance.

Skills

Global Regulatory

Medical Device Regulations

Product Registrations

Regulatory Support

Education

Bachelor's degree in Regulatory Science or related field

Job description

Becton, Dickinson, and Company (BD) is seeking a Senior Regulatory Affairs Specialist to provide regulatory expertise for IPD portfolio at our Sendal Almaraz, Spain facility. You will support global regulatory activities for Class I to II/IIa devices, ensuring compliant documentation and successful market access.

In collaboration with Quality, R&D, Medical Affairs, and Marketing, you will prepare submissions, interpret EU MDR, FDA and international requirements, and guide project teams toward