Senior Specialist Regulatory Affairs

Location: Witney

Abbott is about the power of health. For more than 130 years, Abbott has been helping people reach their potential. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health.

Abbott Diabetes Care is a world leader in glucose monitoring. Our Witney Centre of Excellence develops and manufactures electrodes and biosensors, and has been instrumental in the FreeStyle Libre family including FreeStyle Libre 2, FreeStyle Libre 3 and Libre Sense.

We are hiring a Senior Specialist Regulatory Affairs to join the EMEAP regulatory affairs team, which is growing to support a strong product pipeline.

Primary Job Function

You will be responsible for a portfolio of medical devices and IVDs, leading regulatory activities for new product introductions and significant on-market changes for the Europe, Middle East, Africa and Pakistan (EMEAP) region. You will work as part of a global team to develop, lead and implement strategies ensuring timely introduction of new products onto the international market.

You will coordinate and oversee preparation of complete regulatory submissions and lead interactions with the Notified Body and country regulatory contacts.

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 programs.
• Become a technical expert in ADC devices and support interactions with EU Notified Body, UK Approved Body and competent authorities.
• Manage the creation and development of EU and UK Technical files in accordance with MDR 2017/745 and IVDR 2017/746.
• Provide coaching and mentoring to more 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 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 of Technical File creation and maintenance, as well as post market changes.
• Experience of working with Notified Bodies and/or other regulatory bodies.
• Excellent written and oral communication skills.

In addition to a competitive salary, Abbott offers a highly attractive benefits package including a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme.