Regulatory Affairs Specialist,
Baxter International Inc.
Date: 1 day ago
City: St Albans
Contract type: 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.
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.
THIS IS WHERE you build trust to achieve results.
As a Principal Specialist in Regulatory Affairs, you will support the development of business strategies for compliance with registration plans, ensure the obtaining and maintaining product registrations and local certifications for imported products for the Business Units, provide regulatory support to the company, and participate in optimising improvement processes.
Our customers trust you and appreciate your knowledge and curiosity when finding solutions to meet their needs.
What You'll Be Doing
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.
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.
THIS IS WHERE you build trust to achieve results.
As a Principal Specialist in Regulatory Affairs, you will support the development of business strategies for compliance with registration plans, ensure the obtaining and maintaining product registrations and local certifications for imported products for the Business Units, provide regulatory support to the company, and participate in optimising improvement processes.
Our customers trust you and appreciate your knowledge and curiosity when finding solutions to meet their needs.
What You'll Be Doing
- Serve as a consultant to managers. Lead regulatory activities relating to a specific portfolio of products/projects in a country.
- Lead and manage the regulatory affairs activities for the assigned product portfolio
- Develop and implement regulatory strategies to ensure adherence to local regulations and laws
- Collaborate with cross-functional teams to acquire vital approvals for product registrations and maintain existing licenses.
- Prepare and submit regulatory submissions to health authorities and provide support during audits and inspections.
- Stay updated with the latest regulatory requirements and industry trends to provide mentorship and ensure flawless execution.
- 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.
- Degree in a relevant scientific field
- Experienced specialist in Regulatory affairs within the medical device or pharmaceutical industry
- Proven track record of successfully implementing regulatory strategies and acquiring product registrations
- Solid understanding of regulatory requirements and processes
- 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
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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