Drug Quality & Regulatory Expert – Pre & PostMarket (Spain)
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Job Summary
Drug Quality & Regulatory Expert (Pre & PostMarket) - Spain
At Fresenius Medical Care we are the global leader in kidney care committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality innovative products services and care across the entire healthcare journey. Guided by our visionCreating a future worth living. For patients. Worldwide. Every work with purpose and compassion supported by a global team of over 125000 employees.
Within our Care Enablement segment we develop and provide life-sustaining medical products digital health solutions and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation efficiency and sustainable growth.
Our values guide how we work:
We Care for our patients each other and our communities
We Connect across teams and borders to deliver excellence together
We Commit to doing things the right way growing with purpose and leading kidney care with integrity and innovation
Systems Quality & Regulatory (SQR) a global function within Care Enablement ensuring Fresenius Medical Cares products meet the highest standards of quality safety and regulatory compliance throughout the entire product lifecycle.
The team supports market access innovation and patient safety by driving excellence across manufacturing and supply chain overseeing post-market surveillance and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide!
Your Responsibilities as Drug Quality & Regulatory Expert (Pre & PostMarket) - Spain:This role is responsible for ensuring that the entire lifecycle of the medicationfrom registration through post-marketing surveillance and distributioncomplies with national and international regulations thereby ensuring quality patient safety and business continuity in the clusters assigned countries.
In this role you will act as the regulatory and quality lead for a country ensuring full compliance across the entire product lifecycle. Key responsibilities include:
Ensure efficient and compliant regulatory processes in the assigned country supporting
Market Authorization Product Launch Distribution and Sustained Product Availability.Manage regulatory activities across the full product lifecycle including
Development Registration PostMarket Surveillance and Supply Chain Quality with strong focus on
PVRP and GDP Compliance.Prepare submit and maintain regulatory dossiers and documentation in line with
local and regional regulatory requirements.Promote consistent regulatory strategies and practices and collaborate with key stakeholders and Health Authorities.
Monitor regulatory changes ensure inspection readiness manage compliance risks and provide expert regulatory and quality guidance to internal teams.
Your Profile:
Minimum BA university degree in Pharmacy Pharmaceutical Sciences Biochemistry Biology Bioengineering Health Sciences
or similarAdvanced training in Regulatory Affairs of medicinal products for PharmaAdvanced training in pharmacovigilance
At least 2 - 4 years of experience in a similar position
Minimum of 2 years experience in regulatory affairs in the MedTech /Pharma industry industries
Minimum of 2 years experience in regulatory submissions filings and compliance
Minimum of 2 years of experience in the MedTech industry
Extensive experience in processing documentation and controls
2 3 years of professional experience in GDP-related activities within the pharmaceutical field.
At least 1 year experience in the pharmacovigilance and knowledge of the local regulations related to pharmacovigilance
Good knowledge in applicable legal and regulatory laws of the country in scope
Good Knowledge of ISO 9001 ISO 13485 GxP regulations
Proficiency in Regulatory Software: Familiarity with regulatory management tools and software document management systems and databases.
High proficiency in MS Office applications SharePoint MS-Teams etc with ability to adapt to new technologies
High language proficiency in English and native language (written and spoken)
Other languages are an asset
Our Offer For You:
There is a lot you can discover at Fresenius Medical Care regardless of which field you are an expert and how much experience you have - all dedicated to your professional journey.
Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
Individual opportunities for self-determined career planning and professional development
A corporate culture in which there is enough room for innovative thinking - to find the best solution together not the quickest one
A large number of committed people with a wide range of skills talents and experience
The benefits of a successful global corporation with the collegial culture of a medium-sized company
Hybrid work
In accordance with Organic Law 3/2007 of 22 March FME has set itself the objective of promoting the effective application of the principle of equality between men and women avoiding any type of labour discrimination based on sex thus guaranteeing the same opportunities for entry. Likewise we promote diversity rejecting any type of discrimination for reasons of race sex functional diversity religion sexual orientation sexual identity or any other personal or social condition and we are committed to building an inclusive and enriching environment
About Company
Inovativní produkty, terapie a služby vytváří budoucnost pro naše pacienty, kterou stojí za to žít. Chronická a akutní dialýza ledvin a terapeutické aferézy.
