Global MedTech Regulatory Affairs Specialist

BD; San Agustín del Guadalix; On-site; EUR 36,000 - 39,000; Full time

Job summary

BD is a leading global medical technology company focused on advancing health through innovative products and solutions. The Regulatory Affairs Specialist will lead regulatory strategies, coordinate with product teams, and ensure compliance with evolving medical device regulations across international markets.

The role emphasizes collaboration, data collection for submissions, and life-cycle support for BD products.

Qualifications

• 2-3 years experience in regulatory affairs within medical devices industry.
• Experience with MDR compliance for Class I/IIa/III devices.
• Familiar with ISO 13485, Design Control, Risk Mgmt, V&V processes.
• Proven experience with international registrations/approval processes.

Responsibilities

• Lead regulatory activities within cross-functional product development teams.
• Develop regulatory strategies for product release and changes.
• Review changes, labeling and claims to ensure MDR compliance.
• Support audit readiness and liaise with authorities.
• Create and maintain Technical Files.
• Manage international registrations and market access documentation.
• Prepare regulatory dossiers for Health Authorities.

Skills

Regulatory knowledge

English fluency

Cross-functional collaboration

Audits & regulatory reviews

Job description

BD is a leading global medical technology company focused on advancing health through innovative products and solutions. The Regulatory Affairs Specialist will lead regulatory strategies, coordinate with product teams, and ensure compliance with evolving medical device regulations across international markets.

The role emphasizes collaboration, data collection for submissions, and life-cycle support for BD products.