CQA-RA Specialist - Benelux

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your Role at Vantive

You are accurate. You have an eagle eye, sharp critical thinking, and the willingness to learn, develop and improve. You adopt a challenge and truly apply the collaborative powers of the team to produce excellent results. You are motivated and committed to work. You take pride in getting things done quickly without sacrificing safety or quality.

Your Team at Vantive

Reporting to the CQA/RA Benelux Manager, the CQA-RA Specialist is responsible for ensuring the product registration lifecycle and related processes in Belgium, Luxembourg, and the Netherlands. Further responsibilities include the implementation and maintenance of the Quality Management Systems, as well as guaranteeing that all CQA processes meet applicable EU GDP, EU GMP, ISO and MDD/MDR standards where applicable.

We value both working together as a team and independently, drawing energy from working in collaboration with internal and external stakeholders. As the company evolves, so does the way our team approaches work as it strives to create new development opportunities and innovative ways of working.

What you will be doing:

RA Role (60%) for Renal and Acute Therapy products:

• Ensure timely preparation, submission and appropriate follow-up of variations and renewal applications for drugs. Act as contact person with local authorities.
• Respond to questions from regulatory authorities in agreement with the Global Regulatory Lead.
• Ensure high quality labeling translation and artwork management
• Review promotional materials for compliance with local regulations
• Maintain good relationships with internal (Global Regulatory Leads, Pharmacovigilance, Business partners, Market Planners, …) and external regulatory contacts (local regulatory authorities)
• Monitor applicable EU and local regulations, perform impact analysis where needed and keep internal stakeholders appropriately informed.
• Update and manage regulatory procedures to support continuous process improvements.
• Support stakeholders in implementing new regulatory requirements and on-market activities.
• Follow-up on shortages (drugs & medical devices).

CQA Role (40%):

• Support Quality Management System implementation including local requirements.
• Implement and follow-up Field Actions.
• Handle non conformities, CAPA and change controls.
• Provide support in the case of audits/inspections.

What you will bring:

• Bachelor’s degree or country equivalent in a relevant scientific field
• Preferable prior work experience in regulatory or equivalent experience within a pharmaceutical/medical device company, CRO or similar organization
• Excellent Dutch, French and English
• Good interpersonal and communication skills: ability to collaborate closely with different functions involved and with multicultural teams
• Organizational and project management skills
• Certified RIP from Belgian FAMHP is a plus
• IT functional knowledge in Veeva Vault RIM & PromoMat, TrackWise is an asset

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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