Regulatory Affairs Specialist

2 weeks ago

Johannesburg, South Africa Abbott Laboratories Full time

**Job Title**

**Regulatory Affairs Specialist (1-Year Fixed-Term Contract)**

**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**

This position works out of our Johannesburg location in the Abbott Core Diagnostics Division. 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.

Under the supervision of the Regulatory Affairs Manager for Core Diagnostics in Africa, the Regulatory Specialist is responsible for supporting regulatory compliance and registration for Abbott’s activities for diagnostics in English speaking countries. The Regulatory Affairs Specialist monitors local regulations, e.g. language requirements and medical event reporting, reports new regulations to area regulatory and supports the Regulatory Intelligence process.

**What You’ll Do**:

- 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 Core Diagnostics products intended for distribution in English speaking regulated countries in Africa.
- Engages with the Distributor and liaise with local Regulatory Authorities as applicable and in alignment with regulatory strategy and RA Manager.
- Submit documentation for registration and re-registration for distributor countries.
- Support discussions with local authorities to better understand regulations, build relationship and clarify regulatory requirements.
- Assess product changes to ensure compliance with regulatory requirements.
- Monitor local regulations, e.g. language requirements and medical event reporting and support Regulatory Intelligence process.
- Support and execute strategies to comply with regulations in order to achieve early market entry and cost-effective business operation while maintaining regulatory compliance.
- Participates and represents Abbott CoreDx in trade association meetings and at conferences in alignment with local RA Manager and as applicable.
- Provide support for Adverse Event and Field Action reporting as necessary.
- Maintain internal and divisional regulatory databases (IRIS).
- Support RA and/or QA Manager during internal and external audits as necessary.
- Acts as back-up for local RA Manager for regulatory tasks in the region.

**Required Qualifications**
- Bachelor’s degree in Life Sciences, Engineering, Business Administration or equivalent.
- Technical skills related to IVD or Medical Devices
- Working knowledge of Quality Management Systems
- Fluent in English (written and spoken)
- 3-5 years of experience in the medical device / IVD industry preferably in Regulatory Affairs or Quality Assurance

**Preferred Qualifications**
- Experience to work in international environment/ projects. Cultural sensibility.

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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