Department: QARA

Role reports to: Regulatory Affairs Manager 

Location: Madrid

Purpose

The QARA Specialist coordinates the post marketing surveillance on Medline medical devices, products sold in Spain and Portugal. Provides or requests support to Sales force, Marketing, Product managers or Design department.

Specifically manage Spanish and Portuguese requirements prior to market registration and monitor them in the market afterwards. Key contact with competent authorities, customers and, if applicable, the notified body.

How can you help us?

• Manage the activity related to quality and regulatory matters of the products manufactured and distributed by Medline within the Spanish and Portuguese territory.
• Adopt the role of person responsible for quality in accordance with Spanish and Portuguese regulations.
• Support and achieve any local audit of ISO 9001/14001 certification.
• Training of Medline employees in: warehousing and distribution, requirements of Spanish legislation and other matters.
• Check translation or review approval of Spanish product labels when necessary.
• To be the support position for the quality management of warehouses and distributors in Spain.
• Coordinating prevention activities.
• Coordinate market supervision systems in Spain and Portugal including:
  • Managing customer product complaints
  • Inform manufacturers and suppliers.
  • Inform the competent Spanish and Portuguese authorities when necessary.

Are you our match

• University degree in Chemistry, pharmacy, biomedical science, or applied science. Relevant postgraduate qualification on regulatory affairs.
• Minimum 2-3 years of proven, successful experience in regulatory affairs in medical device companies or healthcare field.
• Project management
• Communication, both written and verbal: Spanish Bilingual, English Advance level. Portuguese, Advisable.
• Planning and organization
• Analytical, critical thinking and problem solving
• The ability to work under pressure and to tight deadlines
• Alongside these basic skills, good understanding of regulatory requirements and current industry practices. Example CE marking (MDR), as well as quality management systems such as ISO 13485, ISO 9001, 14001 and legislation MDD 93/42/EEC y MDR 2017/745.

We have everything covered

• 26 days' vacation - Because we also focus on personal development
• Meal voucher
• A hybrid work system
• Shorter working day every Friday of the year, the months of July and August and at Christmas! – office
• Life insurance 
• Fresh fruit, free coffee and other benefits 
• Comprehensive induction by experienced colleagues - An individually tailored on boarding plan and fixed contacts so you can be off to a great start
• Modern Workplace - Environment with restaurant services, gym, bank, post office and transport
• Employee Assistance Program – So that your mental well-being is taken care of
• A range of training opportunities - We actively support you in your development

At Medline Iberia, we believe that diversity and inclusion are essential for achieving success and fostering innovation. We are committed to promoting an inclusive work environment where everyone is valued and respected for their unique differences. Through our selection processes, we are dedicated to ensuring equal opportunities and fairness for all candidates, regardless of their background, gender, sexual orientation, age, disability, religion, or any other personal characteristic.

Medline is committed to reducing our carbon footprint, developing responsible products, supporting our employees and local communities, and promoting high ethical standards internally and among our supplier partners. Click here to discover what Medline is doing to make healthcare more sustainable for people and the planet.