Senior Regulatory Affairs Specialist

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BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

As a Senior Regulatory Affairs Specialist, you will provide regulatory expertise across BD's infusion preparation and delivery (IPD) portfolio, including disposable infusion sets and accessories used for the administration of fluids and medications.The Sr. Regulatory Affairs position will report to the Sr. Manager, Regulatory Affairs and will be based at the Sendal Almaraz facility in Spain.

The successful candidate will support a global regulatory affairs team through a variety of registration activities that may span new product development, design changes, sustaining engineering, and market access initiatives for Class I and II/IIa devices.

Working closely with Quality, Research & Development, Medical Affairs, Marketing, and other key stakeholders, the candidate will ensure that regulatory requirements are effectively integrated into project planning, execution, and technical documentation, enabling product compliance, global market access, and successful commercialization.

Main responsibilities will include:

• Support product development and change control projects by identifying and interpreting applicable regulatory requirements, providing regulatory guidance throughout the project lifecycle, and reviewing and approving project documentation (e.g., design verification reports, technical documentation, labeling) to support regulatory submissions and compliance activities.

• Contribute to first-to-market commercialization opportunities by delivering timely regulatory support and strategies that facilitate efficient product launches and market access.

• Collaborate cross-functionally with Quality, Research & Development, Medical Affairs, Marketing, and other key stakeholders to ensure regulatory requirements are effectively integrated into project deliverables and technical documentation.

• Prepare, maintain, and update technical documentation, regulatory submissions, and product registrations to support market access and continued compliance in global markets.

• Interpret, assess, and communicate applicable regulatory requirements, standards, and guidance documents (e.g., EU MDR, FDA, ISO standards, and international regulations) to cross-functional teams in a clear and actionable manner.

• Develop, maintain, and continuously improve regulatory procedures and processes to ensure ongoing compliance with applicable regulatory and quality management system requirements.

• Proactively identify regulatory risks, issues, and project roadblocks; analyze data to determine root causes and effectively communicate recommendations and mitigation strategies to project teams and management.

• Provide regulatory support for customer inquiries, product information requests, tender submissions, and other commercial activities as required.

• Support continuous improvement initiatives within Regulatory Affairs, Quality Management Systems, and broader business processes to enhance compliance, efficiency, and organizational effectiveness.

Qualifications

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

• Approximately 3-5 years of experience in Regulatory Affairs within the medical device industry.

• Strong knowledge of medical device regulatory requirements and processes, with experience supporting regulatory submissions, product registrations, technical documentation, or compliance activities.

• Understanding of Regulation (EU) 2017/745 (EU MDR), UK MDR, U.S. FDA requirements, and/or other international regulatory frameworks.

• Experience working within a regulated environment and ISO 13485 Quality Management System

• Experience contributing to technical documentation, change control activities, product development projects, or sustaining engineering initiatives.

• Strong analytical and problem-solving skills, with the ability to interpret regulatory requirements and apply them to practical business situations.

• Ability to manage multiple priorities effectively while maintaining a high level of accuracy and attention to detail.

• Strong written and verbal communication skills, with the