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 responsabilities will include:

• Support product development and change control projects byidentifyingand interpreting applicable regulatory requirements,providingregulatory 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 deliveringtimelyregulatory support and strategies thatfacilitateefficient 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.

• Proactivelyidentifyregulatory risks, issues, and project roadblocks; analyze data todetermineroot 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 asrequired.

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

Salary range for this role: EUR 37,700.