Senior Specialist Regulatory Affairs

Senior Specialist Regulatory Affairs – Abbott, Witney

Abbott is a global healthcare company with more than 130 years of history. The Witney centre of excellence develops and manufactures glucose‑monitoring electrodes and biosensors used by patients.

Location: United Kingdom – Witney, England

Core Job Responsibilities

• Formulate, develop and lead business‑critical regulatory strategies for the EMEAP region.
• Act as the regulatory subject‑matter expert in design control projects, assessing changes and managing roll‑out programmes for existing products and new launches.
• Become a technical expert in ADC devices and support interactions with EU Notified Bodies/UK Approved Bodies and competent authorities.
• Manage the creation and development of EU & UK technical files in accordance with MDR 2017/745, IVDR 2017/746 and applicable regulations.
• Provide coaching and mentoring to junior team members.
• Identify an...