About Abbott

At Abbott, we’re dedicated to helping people live more fully, in everything we do. We’re creating the future of healthcare through life-changing technologies and products that make you healthier and stronger, quickly identify when you have a
medical need, and treat conditions to help you get back to doing what you love.

With headquarters in north suburban Chicago, we serve people in more than 160 countries with leading medical devices, diagnostics, nutrition products and branded generic medicines. Our 115,000 colleagues are helping millions of people to live better and healthier, every day around the world.

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.
• A company named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Spain location in the Diabetes division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

As a Senior Regulatory Specialist , you’ll be responsible for managing an efficient program to ensure that all regulatory activities for Abbott Diabetes Care products are achieved to an agreed schedule in EMEAP. Work with the Regulatory Affairs Manager to develop and implement strategies that will ensure the timely introduction of products onto the market. Coordinate and oversee preparation of complete and scientifically sound regulatory submissions. Lead interactions and discussions with internal and external stakeholders, including regulators, , Government Affairs and Legal to resolve issues arising during the regulatory submission process and post-market to ensure a timely approval process.

What You’ll Do

• Formulate, develop and manage a program to enable all EMEAP registrations, when applicable, are completed efficiently and to an agreed schedule.

• Manage a roll out program for existing products and new launches.

• Work with the Regulatory Management team, Regulatory Affairs colleagues, and cross-functional team to develop and implement strategies that will ensure the timely introduction of products onto the international market.

• Manage the creation and development of Technical files and/or submission documentation for ADC devices in accordance with regulatory requirements, including MDR 2017/745 & IVDR 2017/746.

• Provide guidance to Regulatory colleagues in coordinating the preparation of regulatory submissions.

Sample Requests and Label Copy:

• Manage a program to ensure efficient scheduling of all sample requests.

• Review baseline labelling & translations, marketing and training materials for regulatory compliance within EMEAP.

Projects:

• Undertake specific projects as assigned by the line manager to the agreed timescales.

General:

• Ensure that all documentation is correctly completed to a high standard of quality & clarity.

• Maintain awareness of regulations and guidelines governing the Company and communicate their impact to Global RA and AQR when appropriate.  Advising in the interpretation and application of MD and IVD requirements, as well as the planning and implementation of new and updated regulations.

• Responsible for implementation of new requirements when required. 

• Open and maintain regular communications with any contacts requiring any regulatory involvement.

• Responsible for maintaining the effectiveness of the Quality System at the site location in accordance with Abbott Corporate requirements and applicable regulations.

• Check and complete own training records/status in a timely manner and performs functions in a manner that is compliant with the training system.

• Adhere to all company policies and procedures and training requirements.

Required Qualifications

• Educated to degree level or equivalent preferably in a Scientific discipline e.g. Chemistry, life Sciences, Biology. 

• Experienced in Competent Authority and/or Notified Body regulatory submissions and notifications for in vitro diagnostic devices and/or medical devices.

• Experience of working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC), Medical Device Regulation 2017/745, and/or the IVD Directive (98/79/EC), IVDR 2017/746.

• English proficiency level: upper intermediate.  

• 3-4 Years of experience, both overall and any industry-specific experience needed

Preferred Qualifications 

• Knowledge of the regulatory environment, hands on experience in the registration of medical devices.

• Proven experience of working with Government regulatory stakeholders.

• Ability to establish excellent working relationships with regional and global internal stakeholders and navigate complex matrix environments.Strong communication skills (verbal and written.

• Other qualifications/certifications

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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