Regulatory Affairs Specialist

Baxter Healthcare; St Albans; On-site; GBP 50,000 - 75,000; Full time

Job summary

Join a leading healthcare company as a Principal Specialist in Regulatory Affairs, where you will play a key role in developing regulatory strategies and ensuring compliance with EU regulations. This position offers an opportunity to impact patient lives positively by supporting global teams and maintaining the highest regulatory standards in medical devices.

Qualifications

• Experienced specialist in Regulatory affairs within EU MDR and MDD.
• Proven track record of acquiring product registrations.
• Solid understanding of CE marking processes.

Responsibilities

• Support global regulatory activities and ensure compliance with local laws.
• Prepare submissions to regulatory bodies and provide audit support.
• Collaborate with cross-functional teams for product registrations.

Skills

Communication

Interpersonal skills

Regulatory compliance

Education

Degree in a relevant scientific field

Tools

Trackwise

TCU document control

RIM Vault

Job description

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

#IND-UKOP

#LI-BAXGEN

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.

ApaTech Limited 360 Centennial Avenue Elstree|Hertfordshire|Hertfordshire|WD6 3TJ|United Kingdom