Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
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.
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’ll also have access to:
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.
Job Description
We are recruiting for a Regulatory Operations Specialist I, to join our team in the Sylmar, CA location. In this role, you will be responsible for specialized level work assignments and/or analyses, evaluation, preparation, and management of global regulatory product releases and general support of global regulatory activities.
Daily support of product releases by preparing Global Trade Services (GTS) licenses for products, countries and business partners allowing shipment of product to achieve departmental and organizational objectives.
• Responsible for following SOPs for managing GTS licenses, additional release authorizations (ARAs) and tender support and overall regulatory operations activities.
• Provide support for Product and Country Experts in the set-up for release of new and modified products globally.
• Acts as a regulatory representative responsible for review and analysis of GTS blocked orders, providing guidance and direction on regulatory compliance.
• Reviews and evaluates customer service requests and monitoring of email box for such requests, maintaininga high level of service and follow through on all communications.
• Ensure communications convey all necessary detail and adhere to applicable regulatory standards.
• Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates and IT.
Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Participates in projects affecting GTS licenses and performs other related duties and responsibilities, as assigned
• Associate or Bachelor’s degree
• 1+ years of experience in a similar role from a regulated environment (i.e. medical device, pharmaceutical, aerospace, computer sciences, etc.)
• Proficient with MS Office suite (Word, Excel, Outlook)
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Medical device experience
• Previous experience working in a highly matrixed and geographically diverse business environment
The base pay for this position is
$72,100.00 – $114,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
MD Medical Devices
LOCATION:
United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf