Ingeniero/A De Repuestos (Extremadura)

Ingeniero/A De Repuestos (Extremadura)

13 oct
|
EAG (Empresarios Agrupados - GHESA)
|
Extremadura

13 oct

EAG (Empresarios Agrupados - GHESA)

Extremadura

Senior Regulatory Affairs Specialist (Temporary - 1 year)
We are the people who give possibilities purpose
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, integral market access, and successful commercialization.
Main responsabilities 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 deliverin

📌 Ingeniero/A De Repuestos (Extremadura)
🏢 EAG (Empresarios Agrupados - GHESA)
📍 Extremadura

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