Reg Affairs Manager (Medical Devices)
México Nuevo Uno (México Nuevo) (Fresnillo) Personal services
Job description
JOB DESCRIPTION:
HAVE YOU EVER DREAM OF MAKING AN IMPACT ON THE WORLD?
Become a REGULATORY AFFARIS MANAGER 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 Manager 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.
- Be responsible for obtaining and tracking licenses according regulations
- Conduct an annual registration plan for the region according with commercial and corporate requirements.
- Inform product divisions and the commercial area on the processes of submissions and local approvals and Latin American distributors in charge.
- Maintain and control the record information of all registration activities.
- Ensure the confidentiality of the information of the design files of all products owned by the company.
- Provide regulatory support for the realization of the files to distributors in charge in Mexico, Central America and Caribbean region. 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 directly with Ministry of Health in Mexico and other regulatory agencies in Central America and Caribbean Region.
CAN'T WAIT TO GET STARTED?
To be successful in this role, you will require the following qualifications and experience:
- Minimum 3 years of regulatory experience in Medical Devices as a Manager
- 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
JOB FAMILY:
Regulatory Operations
DIVISION:
MD Medical Devices
LOCATION:
Mexico > Mexico City : Building B
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)