Senior Regulatory Affairs Specialist (Temporary, 1 Year)

About the role

Becton, Dickinson and Company (BD) is hiring a Senior Regulatory Affairs Specialist for a temporary, one-year assignment at its Sendal Almaraz facility in Spain. The role provides regulatory expertise across BD's infusion preparation and delivery (IPD) portfolio, including disposable infusion sets and accessories, and reports to the Senior Manager, Regulatory Affairs. It supports a global regulatory affairs team with registration activities spanning new product development, design changes, sustaining engineering and market access for Class I and II/IIa devices.

Key responsibilities

• Support product development and change control projects by identifying and interpreting regulatory requirements, giving regulatory guidance and reviewing and approving project documentation such as design verification reports, technical documentation and labeling.
• Deliver timely regulatory support and strategies for first-to-market commercialization and efficient product launches.
• Collaborate with Quality, R&D, Medical Affairs, Marketing and other stakeholders so regulatory requirements are integrated into project deliverables and technical documentation.
• Prepare, maintain and update technical documentation, regulatory submissions and product registrations.
• Communicate EU MDR, FDA, ISO standards and other international regulations clearly to cross-functional teams.
• Develop, maintain and improve regulatory procedures, identify regulatory risks and root causes, and support continuous improvement in Regulatory Affairs and quality management systems.
• Provide regulatory support for customer inquiries, product information requests, tender submissions and other commercial activities.

Required profile

• Bachelor's degree in Regulatory Science, Biomedical Engineering, Pharmaceutical Sciences, Life Sciences or a related field.
• About 3-5 years of experience in Regulatory Affairs within the medical device industry.
• Experience in a regulated environment and ISO 13485 QMS.
• Experience with technical documentation, change control, product development or sustaining engineering.

Required skills

• Knowledge of EU MDR, UK MDR, U.S. FDA requirements and other international frameworks.
• Experience supporting regulatory submissions, product registrations, technical documentation or compliance activities.
• Strong analytical, problem-solving, written and verbal communication skills.

The salary range is EUR 37,700 to EUR 60,350 per year.