Post Market QARA

Dedalus; Málaga; Presencial; EUR 40.000 - 70.000; Jornada completa

Descripción de la vacante

Join a leading healthcare technology company as a Post Market QARA in Málaga, Spain. You will ensure quality and regulatory compliance for medical devices, collaborating with various teams to monitor safety and efficacy. This role demands strong analytical skills and experience in regulated industries, offering a chance to impact healthcare positively.

Formación

• Minimum of 3–5 years' experience in a regulated industry.
• Familiarity with ISO 9001, ISO 13485, ISO 14971, and MDR.
• Proficient in data analysis and statistical methods.

Responsabilidades

• Ensure regulatory compliance for Health IT software.
• Lead evaluation of escalated complaints and monitor CAPA processes.
• Conduct Post Market Surveillance activities.

Conocimientos

Analytical skills

Problem-solving skills

Project management skills

Data analysis

Communication skills

Educación

University degree in Engineering, Computer Science, or a scientific discipline

Herramientas

R programming

Descripción del empleo

And do you want to make healthcare safer, better and more reliable?

Join our Team!

Join us as a Post Market QARA atDedalus, one of the world’s leading healthcare technology companies, on our Quality Assurance team based in Spain.

Do the best work of your career and make a profound impact by providing better care for a healthier planet.

What you’ll achieve :

As a Post Market QARA and member of an international team, you will ensure quality, regulatory compliance, and safety and efficacy of our medical devices and non-medical products.

You will :

• Ensure regulatory compliance of Post Market activities for Health IT software medical devices across global markets, including Iberia, DACH, France, and Brazil.
• Participate in product quality and problem management teams to monitor complaint handling, escalation, and resolution in line with regulatory requirements.
• Guide cross-functional teams on compliance matters and ensure that product issues are documented and addressed through timely and effective corrective and preventive actions (CAPA).
• Lead the evaluation and resolution of escalated complaints and critical product issues, assessing risk and monitoring the effectiveness of CAPA and problem management processes.
• Coordinate and conduct Post Market Surveillance activities and prepare formal written reports assessing the adequacy and effectiveness of the processes reviewed.
• Ensure compliance with reporting obligations to regulatory authorities for incidents, trend reporting, corrections, and recalls within regulated timelines.
• Collaborate with internal teams, including clinical analysts, product management, R&D, service, and pre-market QARA to provide feedback on product issues and risk evaluations.
• Ensure that customer and service communications are accurate and compliant with regulatory requirements.
• Identify areas for improvement based on analysis of product issues, customer complaints, quality metrics, and internal audits.
• Provide regular reports on product quality trends and Post Market activities to support management reviews at site, divisional, and healthcare levels.

Take the next step towards your dream career

At Dedalus Life flows through our software . Every day, we do something special by helping caregivers and health professionals deliver better care to their served communities. Take the next step in your career that will make a profound impact.

Here’s what you’ll need to succeed :

• University degree in Engineering, Computer Science, or a scientific discipline, or equivalent experience.
• Minimum of 3–5 years' experience in a regulated industry, preferably medical devices or pharmaceuticals, in roles such as project management, technical support, quality management, or regulatory affairs.
• Familiarity with international medical device regulations and standards such as ISO 9001, ISO 13485, ISO 14971, and MDR.
• Experience with risk management, CAPA, vigilance, Post Market Surveillance, and software development processes.
• Strong analytical, problem-solving, and project management skills.
• Proficient in data analysis and statistical methods; knowledge of R programming is an asset.
• Excellent written and verbal communication skills in English. Spanish, German, French, or Italian is an asset.
• Able to work independently with strong organizational skills and attention to detail.
• Comfortable collaborating with business partners and regulatory agencies to resolve quality issues.

We are Dedalus, come join us

Dedalus is committed to providing an engaging, rewarding work experience that reflects the passion our employees bring to our mission of helping clinicians and nurses deliver better care to their served communities.

Our company fosters a culture where employees are encouraged to learn and innovate, and to enable and enhance clinical co-operation and processes while making a meaningful difference for millions of people around the world. Each person is the end point and the starting point of the Group’s activities and the ultimate beneficiary. For this reason, we are so proud of doing our very special jobs each day.

Our company is enriched by a diverse population of 7,600 people in more than 40 countries that work together to innovate and drive better healthcare options for millions of patients around the world. We are the people of Dedalus.

Application closing date : 05th July 2025

Our Diversity & Inclusion Commitment sets out the Dedalus’ approach to ensuring respect, inclusion, and success for all our colleagues and the wider communities we operate in. We must share our commitment and dedication to ensuring an inclusive and diverse workplace. We recognize that we have improvements to make, and, on this journey, we must remain authentic and realistic but also ambitious.

Life Flows Through Our Software

WeAreDedalus#Together4Success#LifeFlowsThroughOurSoftware