Department: QARA
Role reports to: Regulatory Affairs Manager
Location: Madrid
Purpose: The QARA Specialist coordinates the post marketing surveillance on Medline medical devices and products sold in Spain and Portugal.
This role involves providing or requesting support to the Sales force, Marketing, Product managers, or Design department.
The specialist specifically manages Spanish and Portuguese requirements prior to market registration and monitors them in the market afterwards.
They serve as the 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. Train Medline employees in warehousing and distribution, requirements of Spanish legislation, and other matters. Check translation or review approval of Spanish product labels when necessary. Support quality management of warehouses and distributors in Spain. Coordinate prevention activities. Coordinate market supervision systems in Spain and Portugal, including: Managing customer product complaints. Informing manufacturers and suppliers. Informing 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 in regulatory affairs. Minimum 2-3 years of proven, successful experience in regulatory affairs in medical device companies or the healthcare field. Project management skills. Strong communication skills, both written and verbal: Spanish Bilingual, English Advanced level.
Portuguese is advisable. Planning and organization skills. Analytical, critical thinking, and problem-solving abilities. The ability to work under pressure and meet tight deadlines. Good understanding of regulatory requirements and current industry practices, including CE marking (MDR), quality management systems such as ISO 13485, ISO 9001, ISO 14001, and legislation MDD 93/42/EEC and 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, in July and August, and at Christmas! Life insurance. Fresh fruit, free coffee, and other benefits. Comprehensive induction by experienced colleagues - An individually tailored onboarding plan and fixed contacts to ensure a great start. Modern Workplace - Environment with restaurant services, gym, bank, post office, and transport. Employee Assistance Program – To support your mental well-being. A range of training opportunities - We actively support you in your development.
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