Senior Regulatory Affairs Specialist – Med Devices (EMEA)

Abbott; Witney; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Pension scheme

Share ownership scheme

Private healthcare

Life assurance

Flexible benefits

Job summary

Abbott is seeking a Senior Specialist Regulatory Affairs to join the EMEAP regulatory team. You will lead regulatory activities for new products and significant changes across Europe, the Middle East, Africa and Pakistan, coordinating submissions and interacting with Notified Bodies and regulatory contacts to ensure timely approvals.

You will develop strategies for cutting-edge medical devices and IVDs, oversee EU/UK Technical Files, and mentor junior staff while ensuring global regulatory

Qualifications

• Regulatory expertise across MDR 2017/745 and IVDR 2017/746.
• Experience interacting with Notified Bodies and regulatory authorities.
• Excellent written and verbal communication for cross‑functional teams.

Responsibilities

• Formulate, develop and lead regulatory strategies for the EMEAP region.
• Act as the regulatory SME in design control projects and manage rollouts.
• Become a technical expert in ADC devices and support EU/UK interactions with Notified Bodies and authorities.
• Lead creation and maintenance of EU and UK Technical Files per MDR/IVDR.
• Identify and implement process improvements across global regulatory affairs.

Skills

Regulatory affairs

MDR/IVDR knowledge

Notified Bodies liaison

Education

Degree or equivalent in a scientific discipline

Job description

Abbott is seeking a Senior Specialist Regulatory Affairs to join the EMEAP regulatory team. You will lead regulatory activities for new products and significant changes across Europe, the Middle East, Africa and Pakistan, coordinating submissions and interacting with Notified Bodies and regulatory contacts to ensure timely approvals.

You will develop strategies for cutting-edge medical devices and IVDs, oversee EU/UK Technical Files, and mentor junior staff while ensuring global regulatory