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 and implement process improvements and efficiencies per the global regulatory affairs strategy.

Education

Bachelor’s degree or equivalent, preferably in a scientific discipline such as Chemistry, Life Sciences or Biology.

Minimum Experience Required

• Knowledge of MDR 2017/745 Regulations and ISO13485 is essential; knowledge of IVDR 2017/746 is preferred.
• Experience within a medical device or healthcare manufacturing industry in a regulatory or quality role.
• Experience with technical‑file creation, maintenance and post‑market changes.
• Experience working with Notified Bodies or other regulatory authorities.
• Excellent written and oral communication skills to produce concise reports and documentation and to communicate with internal and external stakeholders.

Benefits

Competitive salary and a benefits package that includes a defined‑contribution pension scheme, a share‑ownership scheme, private healthcare, life assurance, and a flexible benefits scheme which you can tailor to your own requirements.

An equal‑opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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