Regulatory Affairs Specialist – Medical Devices

About the role

Becton, Dickinson and Company (BD) is hiring a Regulatory Affairs Specialist in San Agustin del Guadalix. The specialist gains department and platform influence by cooperating in all regulatory affairs accomplishments and sharing regulatory knowledge, helping to identify, prepare and collect the data needed to obtain and maintain certifications and commercialisation authorisations for BD products. The role combines scientific, regulatory and business knowledge so that products developed, manufactured and distributed meet applicable regulatory requirements and technical standards.

Key responsibilities

• Take part in cross-functional product development teams as the regulatory lead.
• Develop regulatory strategies for product release and product change assessments.
• Review process and product changes, labelling, claims and product complaints to determine the need for regulatory actions and ensure compliance with Medical Devices regulations.
• Represent the RA position and processes during internal and external authority audits.
• Create, maintain and update product Technical Files.
• Handle international product registrations according to country-specific requirements and monitor and report progress.
• Assess changes in regulations and their impact.
• Prepare regulatory documentation for customs release and regulatory dossiers submitted to Health Authorities, maintaining them throughout the product life cycle.

Required profile

• 2-3 years of experience in regulatory affairs within the medical devices industry.
• Experience with Class I/IIa/III products under the MDR.
• Knowledge of the Medical Devices regulatory framework, including MDR CE marking.
• Experience with NB audits and communications.
• Proven knowledge of international registration and approval processes for medical devices.
• Fluent English, as the role is in an international environment.
• Proven computer skills and proven knowledge of design control, risk management and verification and validation processes.

Required skills

• Good working knowledge of ISO 7864, ISO 7886, ISO 6009, ISO 9626, ISO 62366 (usability), ISO 14971 and ISO 13485.
• Knowledge of Design Control, Risk Management and V&V processes.

Salary range: EUR 36,000 - EUR 39,000.