JOB DESCRIPTION:

Regulatory Affairs Specialist / Medical Devices

Mexico City

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 rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.

As the Regulatory Affairs (RA) Specialist, you’ll be responsible to coordinate and manage all related RA local activities for the Abbott Toxicology portfolio in LATAM RA local regional team.

What You’ll Do:

• Request from the corporate office the technical and legal documentation required for the preparation of Health Registration dossiers (New registrations, modifications, extensions) through different submission channels.
• Prepare, analyze, and submit Health Registration dossiers (New Registrations, modifications, extensions), Import Permits, Permits and Advertising Notices to COFEPRIS.
• Submit and collect paperwork at COFEPRIS. Control and reception of the technical and legal documents received in the Department of Regulatory Affairs for use in registration and/or tender processes. Verify that said documents comply with the sanitary and regulatory requirements for proper marketing and distribution in Mexico.
• Interact with the areas of Quality Control, Marketing, Logistics, Government, Sales, Warehousing, and Customs to ensure product availability and avoid problems regarding importation and tender processes.
• Update the databases of records, advertisements, technovigilance, contracts and suppliers.
• Administrative activities for the operation of the area
• Prepare, analyze, and submit product evaluation files to InDRE.
• Surveillance activities.

Required Qualifications

• A minimum of 5 years’ experience in Regulatory Affairs in Medical Devices, ideally in IVDs
• Minimum university level studies with a degree and professional license in health-related areas.
• 6 years of experience in Regulatory Affairs of Medical Devices.
• Knowledge of Medical Device Regulation LGS, RIS, RLGS in Advertising, FEUM, NOM 137, NOM 240, NOM 241.
• Experience in diagnostic agents is desirable.
• Experience in Canifarma.
• Advance level English.
• Must have organizational skills. Thrives in a team environment, assertive communicator, negotiation capabilities/skills.

Apply Now

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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

ID Infectious Disease

        

LOCATION:

Mexico > Mexico City : Tlalpan

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable