QRA Specialist Iberia (Temporary, 1 Year)

About the role

Becton, Dickinson and Company (BD) is hiring a QRA Specialist for Iberia on a temporary basis of 1 year. The specialist joins the local QRA team to carry out Iberia-level Go to Market activities, supporting local stakeholders and regional QRA teams so that regulatory compliance, quality excellence and uninterrupted market access are maintained in line with EMEA QRA priorities.

Key responsibilities

• Support regulatory compliance for the assigned portfolio and country scope (Spain and Portugal), including preparation, submission, tracking and maintenance of product notifications.
• Provide regulatory support to business initiatives, market access projects and tenders, as applicable.
• Review promotional materials and labelling, as assigned, ensuring compliance with regulatory and internal requirements.
• Provide QRS support to business activities and cross-functional projects, working closely with local, regional and global QRA teams.
• Maintain and improve Quality Management System activities, and contribute to certification maintenance and audit readiness, including inspections, training, management reviews and follow-up actions.
• Support CAPA activities and the resolution of quality issues within the assigned scope.

Required profile

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Quality, Regulatory Affairs or a related field, or equivalent experience.
• 1 to 3 years of experience in Quality and/or Regulatory Affairs within a regulated industry.
• Fluent written and spoken English.

Required skills

• Strong knowledge of the European Medical Devices Regulation (MDR), IVDR, ISO 9001:2015, ISO 13485:2016 and local regulations.
• Ability to interpret regulatory requirements, assess their impact and communicate clearly with stakeholders.
• Organizational, analytical and collaboration skills, with the ability to adapt to changing regulatory and business contexts.

The salary range for the role is EUR 32,700 to EUR 52,350 per year.