Senior Regulatory Affairs Specialist

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, because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions, across the spectrum of health, around the world, for all stages of life.

Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

World Leader in Glucose Monitoring, Abbott Diabetes Care designs, develops and manufactures glucose monitoring systems for use in both home and hospital settings. We have a Centre of Excellence in Witney for the development and manufacture of electrodes and biosensors used by patients and healthcare professionals for the day-to-day management of diabetes.

The site has been instrumental in the research, development and manufacture of the FreeStyle Libre Flash Glucose Monitoring System as well as exciting developments in the Libre family including FreeStyle Libre 2, FreeStyle Libre 3 and the Libre Sense system. We are passionate about doing work that improves the quality of people’s lives.

We’re hiring a Senior Specialist Regulatory Affairs to join the EMEAP regulatory affairs team, which is growing to meet the demands of the business and to support a strong product pipeline.

Primary Job Function

You will be responsible for a portfolio of cutting-edge medical devices & 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 that will ensure the timely introduction of new products onto the international market in a fast-paced environment.

You will coordinate and oversee preparation of complete and scientifically sound regulatory submissions and lead interactions with the Notified Body and country regulatory contacts to facilitate the regulatory submission review process to ensure a timely approval process.

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 for existing products and new launches.

Become a technical expert in ADC devices and support interactions with EU Notified Body/UK Approved Body, as well as competent authorities, as required

Manage the creation and development of EU & UK Technical files in accordance with MDR 2017/745, IVDR 2017/746 and other application regulations.

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 e.g. Chemistry, life Sciences, Biology.

Minimum Experience Required

Knowledge of MDR 2017/745 Regulations and ISO13485 is essential, additionally, 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

You need to have excellent written and oral communication skills necessary to be able to produce succinct reports and documentation and to effectively communicate with other departments, managers and external regulatory organizations.

In addition to a competitive salary, Abbott offers a highly attractive benefits package which 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.