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Quality and Regulatory Affairs Specialist (IVD)

On-site in Zaragoza·Full-time·Added 3 days ago (last checked 26 Oct)

Diagnóstica Longwood

13 open roles

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Our summary

Work mode: On-site, Zaragoza
Contract: Permanent, full-time hours
English: Required
Experience: 3+ years
Education: University degree
Benefits: Private health insurance

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Skills

This job advert was originally written in Spanish.

Requirements

What we're looking for

Previous experience of at least 3 years within the medical device sector in QA/RA departments, with experience in transition or registration under IVDR 2017/746.

Required competencies.

Proficiency in the ISO 13485 standard and ISO 14971 risk management.
Familiarity with conformity assessment processes for obtaining CE marking with top-tier Notified Bodies.
Medium - high level of English.
High scientific rigor and organizational capacity.
Attention to detail and excellent communication skills for multidisciplinary work.

Education & certifications

Degree/Bachelor's in Health Sciences or related fields (Biotechnology, Biology, Biochemistry, Pharmacy). Postgraduate training or a specialized Master's in Medical Device Regulatory Affairs is highly valued.

Pay & benefits

What you'll get

Immediate incorporation into a leading company in its sector, offering stability, a dynamic environment, and professional development
Social benefits such as private medical insurance, among others, and continuous training
Dynamic and collaborative work environment.

The role

With more than 10 years of experience and a biotechnology background, Blackhills Diagnostic Resources BDR is focused on the research, development, manufacturing, and sale of in vitro diagnostic products (CE-IVD).

We are selecting candidates to become part of our DNA within the quality team,

Quality and Regulatory Affairs Specialist (IVD) whose mission will be to carry out regulatory affairs strategies for the IVD product portfolio, ensuring the preparation and maintenance of the technical documentation for class C products (STED) necessary to successfully pass Notified Body assessments, obtain CE marking under regulation (EU) 2017/746 (IVDR), and maintain the Quality Management System under the ISO 13485 standard.

What you'll do

The role will include, among others, the following duties:

Compliance with IVDR regulations.
Preparation of Technical Documentation such as product technical documentation files (STED).
Relationship with Notified Bodies: Act as an interlocutor with Notified Bodies and Competent Authorities (such as the AEMPS).
Maintenance of ISO 13485.
Vigilance and Post-market surveillance.
Verify and approve labeling, safety data sheets, instructions for use (IFU), of products and associated promotional material to ensure compliance with regulatory requirements.

Minimum required training.

What we offer

Work with us

About Diagnóstica Longwood

Diagnóstica Longwood is a Spanish company specializing in the distribution of medical diagnostic equipment and reagents, serving the healthcare sector. Based in Madrid, the company provides products and support for clinical laboratories and veterinary diagnostics, operating across Spain with a focus on technical service and sales.

For international professionals, Diagnóstica Longwood offers opportunities in field sales and technical roles across Spain, with positions covering regions such as Centro, Sur, and Cataluña. The company uses FactorialHR for its careers page, indicating a structured HR process. While not a globally recognized brand, it is a relevant player in the Spanish diagnostic sector, and roles may require Spanish language proficiency and local market knowledge.

Employees: 1,000
Headquarters: Madrid, Spain
In Spain: Madrid

Good to know if you are moving

The company is based in Madrid, Spain, and focuses on diagnostic imaging and reagents for the healthcare and veterinary sectors.
Open roles include field sales positions (FAS) covering different regions of Spain, which may require travel and local market knowledge.
The recruitment process is managed through FactorialHR, a Spanish HR platform, indicating a structured hiring process.
Given the specialized nature of the business, fluency in Spanish is likely essential for sales and technical roles.
The company's website is in Spanish, suggesting that the working language is primarily Spanish.

In their own words

Additional information

Responsible: BLACKHILLS DIAGNOSTIC RESOURCES S.L.U.; Purpose: So that the candidate can be part of the selection process initiated by BLACKHILLS DIAGNOSTIC RESOURCES S.L.U.; Legitimization: Consent; Recipients: Data will not be transferred to third parties, except for legal obligations; Rights: Access, rectification, and erasure, as well as other rights, as explained in the additional information; Additional and detailed information: https://www.bdrdiagnostics.com/es/politica-de-datos/.

All open roles at Diagnóstica Longwood