JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

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 recognized as a great place to work in dozens of countries around the world and 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.

About Medical Devices

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine \xef\xac\x81ngersticks.

The opportunity

Regulatory Affairs & Quality coordinator

The position works out of our UAE location in Abbott Diabetes Care division

The role is on Fixed term contract for 1 year.

About Diabetes Care division

We\xe2\x80\x99re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We\xe2\x80\x99re revolutionizing the way people monitor their glucose levels with our new sensing technology.

Objective:

Support registration of new medical device products and maintain current registrations according to Abbott global and local procedures and local laws and regulations in the Gulf countries.

What You\'ll do:

Regulatory Affairs:

Prepare registration files as per country specific requirements and make sure to meet the planned submission/approval dates in coordination with local distributor and engaging with MOH in country of responsibility.

Maintain effective communication with the local agent and MOH officials across the region by field visits.

Coordinate, prepare and review regulatory submissions within Middle East.

Review, submit and obtain approval for a new product, variation, and renewal.

Review and approve the promotional materials per the agreed guidelines & within the required time- frame.

Manage communications between Regulatory Affairs teams and Distributor partners to facilitate the registration and renewal of products across countries within the Gulf, Iran and Pakistan.

Responsible for reporting all adverse events to authorities.

Review artwork and labelling to ensure adherence with regulations and registered details.

Produce weekly schedules summarizing submission status for various products in each country.

Update the Product Registrations database.

Preferred Qualification:

Bachelor\'s degree (or equivalent) in science.

Experience/ Background:

Preferably 1-3 years\xe2\x80\x99 experience in a regulated industry (e.g., medical products, nutritional\xe2\x80\x99s).

Knowledge of PC-based applications, such as Microsoft Office.

Proficiency in English language.

Impact of position:

Successful implementation of quality processes and compliance assurance with Abbott\'s quality procedures and regulations.

Meet all registration due data to ensure timely product launches.

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.

Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

The salary for this role is between: N/A

JOB FAMILY: Regulatory Operations

DIVISION: ADC Diabetes Care

LOCATION: United Arab Emirates
Dubai : Building #49

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Not Applicable

Abbott