Regulatory Affairs Associate Director.

Baxter; St Albans; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading medical device company in St Albans is seeking a Regulatory Affairs Associate Director to oversee the strategic direction of its EU Devices Policy. You will develop innovative regulatory strategies and manage relationships with regulatory authorities while ensuring compliance with EU MDR standards. The ideal candidate will have significant experience in regulatory affairs and possess strong leadership and communication skills.

Qualifications

• Significant experience in Regulatory Affairs within EU MDR and MDD.
• Established relations with regulatory authorities.
• Ability to work effectively in a multinational/multicultural environment.

Responsibilities

• Develop and implement plans related to life cycle management of medical devices.
• Direct regulatory professionals in strategic plans and authority interactions.
• Represent the company at regulatory meetings and influence policies.

Skills

Proactive development of innovative approaches related to CE marking

Expertise in EU MDR and MDD regulations

Excellent communication skills

Ability to lead and mentor

Strong interpretation and application of regulations

Education

Degree in a relevant scientific field

Job description

Overview

You will be responsible for the strategic direction of the EU Devices Policy and Strategy team. This will include the development and implementation of plans related to life cycle management of medical devices in the EU. You will play a pivotal role in the shaping of innovative regulatory strategies in the region, ensuring all Baxter business segment medical devices (NPD and sustaining) are handled under optimal conditions for regulatory success.

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, assess probability of occurrence, and ensure implementation of mitigation plans and follow-ups
• Represent Baxter at regulatory meetings, including industry Regional Associations, influencing the regulatory environment and ensuring 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
• Develop and oversee procedures to ensure Baxter submissions are in line with 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 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
• Ability to work effectively in a multinational/multicultural environment
• Excellent written and verbal communication, presentation, and facilitation skills
• Significant experience in Regulatory Affairs within the EU MDR and MDD, and established relations with regulatory authorities
• Experience with regulations, current industry practices, and strong interpretation and application skills
• Ability to lead, mentor, and develop others for future growth and development
• Degree in a relevant scientific field

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. This description reflects the role of Regulatory Affairs Associate Director and is intended to outline responsibilities and requirements for the position.