Abbott Especialista de Asuntos Regulatorios in Cuidad de Mexico, Mexico
HAVE YOU EVER DREAM OF MAKING AN IMPACT ON THE WORLD?
Become a REGULATORY AFFARIS SPECIALIST for ABBOTT
If you are inspired by our commitment to improving patient care, this role might well be what you have been looking for!
HOW WILL YOU MAKE A DIFFERENCE?
As a Regulatory Affairs Specialist in Abbott you will be responsible for:
Specialized level work assignments coordinating registration activities in Mexico, Central America and Caribbean region, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.
Prepares robust regulatory applications for Mexico to achieve departmental and organizational objectives.
Provides regulatory support to the distributors in Central America to complete annual submission plan.
Reviews and evaluates potential changes to the products that could impact the current licenses, also changes in regulations that could impact to the company and therefore products and licenses.
May interface with Ministry of Health in Mexico and other regulatory agencies in Central America.
Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
CAN’T WAIT TO GET STARTED?
To be successful in this role, you will require the following qualifications and experience:
Minimum 4 years of regulatory experience in Medical Devices
Must have experience in submissions of medical devices in Mexico, Central America and Caribbean region and Central America.
Advanced level of English (oral and written)
Ability to self-direct daily priorities and activities.
Business/professional writing skills and competency required.
Explains complex information to others in straightforward situations.
Experience with local regulatory institutions, COFEPRIS
Knowledge in regulatory matters for medical Devices in Central America & Caribbean
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com