QRA Specialist Iberia

Salary range for this role: EUR 36.000

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

€32,700.00 - €52,350.00 EUR Annual

Education and Experience:

- Bachelor´s degree in Life Sciences, Engineering, Pharmacy, Quality, Regulatory Affairs, or a related field, or equivalent experience.

- 1 - 3 years experience in Quality and/or Regulatory Affairs within a regulated industry.

Knowledge and Skills:

- Strong knowledge of European Medical devices Regulation (MDR), IVDR, ISO 9001:2015, ISO 13485:2016 and local regulations.

- Ability to interpret regulatory requirements, assess impact, and communicate effectively to stakeholders.

- Strong organizational, analytical, and collaboration skills, with the ability to adapt in evolving regulatory and business contexts.

- Fluent English language skills. both written and verbal, with the ability to effectively communicate and collaborate in an internal business environment.

Job Description

The QRA Specialist Iberia serves as part of the local QRA team to conduct the activities at Iberia level for Go to Market activities, conducting the support to local stakeholders and regional QRA teams to ensure regulatory compliance, quality excellence, and uninterrupted market access while aligning local execution with EMEA QRA priorities.

The position requested will be working within the Iberia QRA team

Main responsabilities will include:

- Support regulatory compliance for the assigned portfolio and country scope (Spain plus Portugal) for the assigned portfolio and country scope, including preparation, submission, tracking and maintenance of product notifications.

- Provides regulatory support to business initiatives, market access projects, tenders, as applicable.

- Reviews promotional materials and labelling, as assigned, ensuring compliance with applicable regulatory and internal requirements.

- Provides QRS support to business activities and cross-functional projects, while collaborating closely with local, regional, and global QRA teams.

- Support maintenance and continuous improvement of assigned Quality Management System activities, ensuring compliance with internal procedures and applicable external requirements.

- Contribution to certification maintenance and audit readiness, supporting inspections, training activities, management reviews, and follow-up actions.

- Support CAPA activities, and resolution of quality issues within the assigned scope.

- Supports the QRA team and broader organization on additional activities as required, adapting to evolving business and priorities while contributing to overall QRA and business success.

Primary Work LocationESP San Agustin del GuadalixAdditional LocationsWork Shift

Optional Skills

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