Regulatory Affairs Specialist at Baxter International Inc.

, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

01 Apr, 26

Salary

0.0

Posted On

01 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, EU MDR, MDD, Regulatory Strategies, Product Registrations, CE Marking, Communication Skills, Interpersonal Skills, Trackwise, TCU Document Control, RIM Vault, Cross-Functional Collaboration, Compliance, Audits, Inspections, Industry Trends

Industry

Medical Equipment Manufacturing

Description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Baxter is seeking a highly skilled and motivated individual to join our team as a Principal Specialist in Regulatory Affairs. This is an outstanding opportunity to contribute to the success of a world-class healthcare company and make a meaningful impact on patients' lives. As a Principal Specialist in Regulatory Affairs, with experience in EU MDR and MDD, you will work with the relevant global partners to develop and Implement regulatory strategies. You will provide support to the business to ensure/ maintain compliance with the regulations. You will also provide regulatory support/ guidance to global RA colleagues and other stakeholders within specific segments/ divisions. What you'll be doing: Support global regulatory and other stakeholders with regulatory activities relating to a specific portfolio of products/projects. Act as EU Policy and Strategy Lead, managing the regulatory affairs activities for the assigned segment/ division /product portfolio Support the development and implementation of regulatory strategies to ensure adherence to local regulations and laws Collaborate with cross-functional teams to support vital approvals for product registrations and maintain existing licenses. Support the preparation and submissions to regulatory bodies/ health authorities and provide support during audits and inspections. Stay updated with the latest regulatory requirements and industry trends to provide support/ guidance and ensure flawless execution. Provide clear communications/ training to global RA/ other stakeholders on regulatory requirements / changes related to EU MDR Collaborate closely with regional and global regulatory teams to align strategies and exchange practical approaches. Support the Legal Manufacturer (BHSA) in its fulfilment of its regulatory responsibilities under the MDD and MDR. Support BHSA and other Baxter legal manufacturers in CE mark related regulatory activities in front of the Notified Bodies and relevant Competent Authorities. What you'll bring: Degree in a relevant scientific field Experienced specialist in Regulatory affairs within the EU MDR and MDD. Proven track record of successfully implementing regulatory strategies and acquiring product registrations Solid understanding of regulatory requirements and processes related to CE marking of medical devices Excellent communication and interpersonal skills Experienced using systems such as Trackwise / TCU document control / RIM Vault Ability to work independently and collaborate effectively in a cross-functional team environment #IND-UKOP #LI-BAXGEN Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. 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. 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. No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.

Responsibilities

The Principal Specialist in Regulatory Affairs will support global regulatory activities and manage regulatory affairs for specific product portfolios. This includes developing regulatory strategies, collaborating with cross-functional teams, and ensuring compliance with local regulations.