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- Tasks: Join us as a Regulatory Affairs Specialist, ensuring compliance and supporting product registrations.
- Company: Baxter is a leading healthcare company dedicated to saving and sustaining lives worldwide.
- Benefits: Enjoy a collaborative culture, impactful work, and opportunities for professional growth.
- Why this job: Make a real difference in patients' lives while working with innovative medical products.
- Qualifications: Degree in a scientific field and experience in EU MDR and MDD regulatory affairs required.
- Other info: Flexible working arrangements and commitment to diversity and inclusion.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Regulatory Affairs Specialist
Company: Baxter International Inc.
Baxter believes every person deserves a chance to live a healthy life. This role is an opportunity to contribute to a worldâclass healthcare company and make a meaningful impact on patients\â lives.
Responsibilities
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 crossâfunctional 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.
Qualifications
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.
Experience using systems such as Trackwise / TCU document control / RIM Vault.
Ability to work independently and collaborate effectively in a crossâfunctional team environment.
Seniority Level
MidâSenior level
Employment Type
Fullâtime
Job Function
Legal
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.
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Regulatory Affairs Specialist, employer: Baxter International Inc.
Contact Detail:
Baxter International Inc. Recruiting Team
StudySmarter Expert Advice đ¤Ť
We think this is how you could land Regulatory Affairs Specialist,
â¨Tip Number 1
Familiarise yourself with the latest EU MDR and MDD regulations. Understanding these frameworks will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
â¨Tip Number 2
Network with professionals in regulatory affairs, especially those who have experience with Baxter or similar companies. Engaging in conversations can provide insights into the company culture and expectations, which can be invaluable during the application process.
â¨Tip Number 3
Prepare to discuss specific examples of how you've successfully implemented regulatory strategies in the past. Being able to articulate your experiences clearly will set you apart from other candidates.
â¨Tip Number 4
Stay informed about current trends and challenges in the medical device industry. This knowledge will not only help you answer questions more effectively but also show your passion for the field and your proactive approach to professional development.
We think you need these skills to ace Regulatory Affairs Specialist,
Some tips for your application đŤĄ
Understand the Role: Before applying, make sure to thoroughly read the job description for the Regulatory Affairs Specialist position at Baxter. Understand the key responsibilities and required qualifications, especially regarding EU MDR and MDD experience.
Tailor Your CV: Customise your CV to highlight relevant experience in regulatory affairs, particularly your work with EU regulations. Emphasise any successful strategies you've implemented and product registrations you've acquired.
Craft a Compelling Cover Letter: Write a cover letter that connects your background to Baxter's mission of saving and sustaining lives. Mention specific examples of how your skills align with the role and how you can contribute to their regulatory strategies.
Highlight Communication Skills: Since excellent communication is crucial for this role, ensure your application reflects your ability to convey complex regulatory information clearly. Provide examples of past experiences where you successfully communicated with stakeholders or trained teams.
How to prepare for a job interview at Baxter International Inc.
â¨Understand Regulatory Frameworks
Make sure you have a solid grasp of the EU MDR and MDD regulations. Be prepared to discuss how these frameworks impact product registration and compliance, as this will demonstrate your expertise in regulatory affairs.
â¨Showcase Your Communication Skills
As a Principal Specialist, you'll need to communicate complex regulatory information clearly. Practice explaining regulatory concepts in simple terms, as this will highlight your ability to train and guide others effectively.
â¨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world regulatory scenarios. Think of examples from your past experience where you successfully navigated regulatory challenges or implemented strategies.
â¨Stay Updated on Industry Trends
Research the latest trends and changes in the regulatory landscape. Being knowledgeable about current events in healthcare and regulatory affairs will show your commitment to staying informed and proactive in your role.
