BAXTER Hiring For Specialist, Regulatory Affairs at Navan, County Meath Full Time

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

The purpose of this role is to provide Regulatory Affairs support for Baxter Healthcare in the Western Europe region. The professional candidate should have a good understanding and working knowledge of the EU MDR Regulation, Knowledge and experience of the regulations in other jurisdictions in the region such as UK and Switzerland will also be required.

A substantial part of the role will relate to ensuring the MDR obligations are met for economic operators. This will include maintenance of documentation demonstrating fulfilment of the various economic operators’ obligations and of progress and status reports.

The role also requires the provision of regulatory input to change control and commercial release processes and engagement with various internal legal manufacturers.

When required, regulatory support shall be provided to marketing, sales, operations, and other company stakeholders. Support of regional device registrations and tender activities may be required from time to time.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

108497