Regulatory Specialist jobs in United Arab Emirates

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:

1. Career development with an international company where you can grow the career you dream of.
2. 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.
3. 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.

Regulatory Affairs Specialist-IVDR

This position works out of our UAE location in the Abbott Rapid Diagnostics Infectious Diseases. This is a fixed term contract role for 1 year.

MAKING A DIFFERENCE IN GLOBAL HEALTHCARE

We are the world leader in Rapid Diagnostics at the point of care. Working with us, you'll tackle a wide array of problems including some of the world's greatest healthcare challenges, while experiencing a myriad of cultures, geographies, and technologies.

For the Abbott Rapid Diagnostics Infectious Disease Business Unit, we are looking for a talented and dynamic Regulatory professional to coordinate and manage all related RA activities for the Abbott portfolio in a designated list of countries as part of the EMEA RA regional team.

What You'll Do:

1. Support and develop regulatory submission plan for the region in terms of IVDR transition project in collaboration with Global RA IVDR project team, Legal manufacturing sites, supply chain, marketing, commercial and Distributor countries.
2. Assist to manage applicable change control projects for regional team by working closely with relevant manufacturing sites and other functions to obtain all necessary dossiers to support product registration, or amendment to existing product certificates and maintain database with risk escalation if necessary.
3. Report submission status (IVDR, Change Control) via defined Key Performance Indicators into necessary database.
4. Provide secondary support as backup towards local Regulatory Affairs matters as applicable.
5. Track applicable regulatory milestones in internal Regulatory database.
6. Represent RA and/or EMEA at relevant meetings such as IVDR meetings or change control meetings.
7. Support Abbott strategic Quality and Regulatory Affairs Goals and objectives.
8. Monitor developing regulations and gather regulatory intelligence that may be relevant to the business. Conduct impact assessment and disseminate as appropriate to key stakeholders.
9. Ad hoc duties as deemed necessary for the position and business.

Required Qualifications:

1. BSc or equivalent.
2. A minimum of 2 years experience in Regulatory Affairs in Medical Devices, ideally in IVDs.

Competencies and Attributes:

1. Demonstrable working knowledge of the medical diagnostics industry in the regions they will support.
2. Demonstrated capacity in project management.
3. Able to navigate in a cross-functional environment.
4. Knowledge of the regulatory environment (local MOH regulations), legislation, industry standards and guidance.
5. Excellent written and oral communication skills in English.
6. Strong interpersonal skills.
7. Highest levels of integrity and diplomacy.
8. Capacity to maintain the highest levels of confidentiality internally and externally.