Regulatory Affairs Specialist Middle East

4 weeks ago

Riyadh, Saudi Arabia Abbott Laboratories Full time

**About Abbott**

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 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.

**The Opportunity**

We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

**What You’ll Do**

Under the supervision of the Regulatory Affairs Manager for CoreDx Saudi Arabia, the Regulatory Affairs Specialist is responsible for supporting regulatory compliance and registration for Abbott's activities for diagnostics in the Saudi Arabia.
- Responsible for the implementation of regulatory compliance as required by international and local regulations and Abbott policies and procedures.
- Responsible for supporting and maintenance of regulatory approval of all CoreDx products intended for distribution in Saudi Arabia.
- Submit documentation for registration and re-registration with distributor countries.
- Support discussions with authorities to better understand regulations, build relationship and clarify issues.
- Assess product changes, to ensure compliance with regulatory requirements.
- Monitor local regulations, e.g. language requirements and medical event reporting.
- Support and execute strategies to comply with regulations in order to achieve early market entry and cost-effective operation of the business while maintaining regulatory compliance.
- Provide support for Adverse Event and Field Action reporting as necessary.
- Maintain internal and divisional regulatory databases (IRIS).
- Provide support during audits as necessary.
- Attend at least one RA-related developmental course (Abbott or Non-Abbott) as part of overall development plan.

**Required Qualifications**

Bachelor's degree in Life Sciences, Engineering or equivalent.

**Preferred Qualifications**
- Technical skills related to IVD or Medical Devices
- Fluent in English (written and spoken)
- Preferably 1-3 years of experience in the medical device / IVD industry preferably in the area of Regulatory Affairs or Quality Assurance

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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