Regulatory Intelligence Specialist / Medical Devices

JOB DESCRIPTION:
Regulatory Intelligence Specialist (RIS) – Medical Devices Division
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
WHO WE WANT
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement with processes.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure deliverables are complete in meeting regulations and expectations.
• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
WHAT YOU’LL DO
Global Regulatory Operations is seeking a Regulatory Intelligence Specialist to join our team
This position is focused on new and changing regulations that enable global market access for new and innovative medical devices and supports compliance continuity for marketed devices. Assisting in the process to evaluate proposed regulatory changes in major markets within the CALA Region, the Regulatory Affairs Intelligence Specialist:
• Monitors and fact-checks new or changing global regulations
• Tracks and documents regulations within the regulatory intelligence systems
• Supports the communication of emerging regulations, documents for comment, and regulations in implementation
• Performs regulatory investigations to assess medical device regulatory changes within a specific country or region
• Supports the maintenance of, or continuous improvement of quality system procedures, and documents
• May train others on systems and processes
• Facilitates the collection and reporting of data in support of key performance indicators
• Gathers additional data to support interpretation, and aid businesses in determining impact
• Support all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements
• Complies with regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, etc.
• Performs other related duties and responsibilities, on occasion, as assigned
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
• Bachelor’s degree (or equivalent)
Advanced english
• 3 years’ experience in Medical Devices, or a regulated industry (e.g., nutritional, pharma) preferred. Experience in a Regulatory or Quality role, a plus.
• Ability to work within a fast-paced and matrixed team environment
• Strong verbal and written communication skills · Strong attention to detail and organizational skills
• Proficient in Excel, and all programs with MS Office suite (Word, PowerPoint, Outlook)
• Experience in program management a plus
• Experience with document management systems a plus
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:MD Medical Devices
LOCATION:Mexico > Mexico City : Building B
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:Yes, 25 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Not Applicable