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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 healthcare while working with innovative products and passionate teams.
- Qualifications: Degree in a scientific field and experience in EU MDR and MDD regulatory affairs required.
- Other info: This role offers the chance to work with global partners and stay ahead of industry trends.
The predicted salary is between 36000 - 60000 £ per year.
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.
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.
Regulatory Affairs Specialist employer: Baxter
Contact Detail:
Baxter Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist
✨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.
✨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.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully implemented regulatory strategies in the past. This will showcase your practical experience and problem-solving skills during the interview.
✨Tip Number 4
Research Baxter's product portfolio and recent innovations. Being knowledgeable about their offerings will allow you to tailor your responses and show genuine interest in the company's mission.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Regulatory Affairs Specialist position at Baxter. Familiarise yourself with EU MDR and MDD regulations as they are crucial for this role.
Tailor Your CV: Customise your CV to highlight relevant experience in regulatory affairs, particularly your work with EU regulations. Emphasise any specific achievements or projects that demonstrate your expertise in compliance and product registration.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also conveys your passion for the healthcare industry and how your skills align with Baxter's mission. Mention your understanding of their products and how you can contribute to their success.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents. Check for spelling and grammatical errors, and ensure that your information is clear and concise. A polished application reflects your attention to detail, which is vital in regulatory affairs.
How to prepare for a job interview at Baxter
✨Know Your Regulations
Familiarise yourself with the EU MDR and MDD regulations. Be prepared to discuss how your experience aligns with these frameworks and how you can contribute to compliance at Baxter.
✨Showcase Your Communication Skills
As a Regulatory Affairs Specialist, clear communication is key. Prepare examples of how you've effectively communicated complex regulatory information to diverse stakeholders in the past.
✨Demonstrate Cross-Functional Collaboration
Highlight your experience working with cross-functional teams. Be ready to share specific instances where your collaboration led to successful product registrations or compliance outcomes.
✨Stay Updated on Industry Trends
Research the latest trends in regulatory affairs and be prepared to discuss how these may impact Baxter's operations. Showing that you're proactive about staying informed will impress your interviewers.
