Seeking trilingual profiles for a rewarding role!
Req # JR - 132671 Location Braine-l'Alleud, Wallonia, Belgium Job Category Regulatory Affairs Date posted 04/03/2024Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Are you a skilled administrative professional with a passion for Healthcare? Do you speak Dutch, French, and English fluently? Look no further than Baxter!
You are accurate. You have an eagle eye, a 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.
As a global leader in medical technology, we're seeking talented individuals like you to join our team as Regulatory Affairs Specialists.
In this exciting role, you'll be responsible Renal and Acute Therapy products:
Ensure timely preparation, submission and appropriate follow-up of variations and renewal applications. 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 partners appropriately informed.
Provide regulatory guidance to business, tenders and project teams
QA Support
Support Corporate Quality Systems implementation including local requirements to CQA and distribution
Coordinate Field Actions implementation
Handle non conformities, CAPA and change controls
Provide support in case of inspections
Requirements:
Proficiency in Dutch, French, and English (written and spoken)
Strong attention to detail and dedication to accuracy
Previous experience/background as Medical translator, Medical secretary or similar
Excellent communication and interpersonal skills
Proficiency in Microsoft Office
If you're ready to take your career to the next level and make an impact in the healthcare industry, apply now to become a part of the Baxter team!
We look forward to hearing from you!
Reasonable Accommodations
Baxter 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.
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