Regulatory Affairs Associate Director.

Baxter International, Inc.; England; On-site; GBP 70,000 - 90,000; Full time

Job summary

A global healthcare company is seeking a highly skilled Regulatory Affairs Associate Director in the United Kingdom. The role involves developing regulatory strategies for medical devices, managing regulatory submissions, and ensuring compliance with EU regulations. The ideal candidate has significant experience in regulatory affairs and a degree in a relevant scientific field. Excellent communication skills and the ability to work in a diverse environment are essential.

Qualifications

• Significant experience in Regulatory affairs within the EU MDR and MDD.
• Established relations with regulatory authorities.
• Strong experience with interpretation and applications of regulations.

Responsibilities

• Develop innovative approaches related to CE marking of medical devices.
• Direct regulatory professionals in strategic plans and submissions.
• Represent Baxter at regulatory meetings and ensure compliance.

Skills

Multinational/multicultural work

Excellent communication skills

Regulatory affairs experience

Team leadership

Knowledge of EU MDR and MDD

Education

Degree in a relevant scientific field

Job description

Overview

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 Regulatory Affairs Associate Director. 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

What you\'ll be doing

• Proactively develop new innovative approaches related to CE marking of medical devices
• Direct regulatory professionals within the Business segments, in the development of strategic plans, regulatory submissions and authority interactions.
• Work with global regulatory partners to identify and prioritise key areas of risk, and probability of occurrence, as well as ensuring implementation of mitigation plans and follow ups.
• Represent Baxter at regulatory meetings, including industry Regional Associations Influencing the regulatory environment and ensure Baxter\'s position is heard at a European level.
• Provide expert interpretation and advice on existing, pending and proposed regulations/guidance documents, ensuring assessments are documented.
• Responsible for developing and overseeing procedures to ensure Baxter submissions are in line with the crucial standards and content specifications as per regulations (e.g. EU MDR).
• Represent the Legal Manufacturer in all regulatory activities (including surveillance audits).
• Develop and maintain a robust dialogue around the evolving EU, UK and Swiss regulatory landscape, both internally and externally.
• Engage with senior leaders in the EU/ EMEA geographies to understand and integrate positions on the strategic and practical implications of current and forthcoming regulatory policies, developing the Baxter position to be shared internally and externally.
• Coordinate/ collaborate with multiple internal partners (Government Affairs, EHS, Legal, Quality etc.) on regulatory policy priorities and changes potentially impacting these functions.

What you\'ll bring

• Ability to work optimally in multinational/multicultural environment
• Excellent written and verbal communication, presentation, and facilitation skills
• Significant experience Regulatory affairs within the EU MDR and MDD, and established relations with regulatory authorities
• Experienced knowledge of regulations, current industry practices, and strong experience with interpretation and applications
• Ability to lead, mentor, and develop others for future growth and development
• Degree in a relevant scientific field

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.

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