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 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 115,000 colleagues serve people in more than 160 countries.

Our location in Irving, TX is looking for a Regulatory Specialist I. This new team member performs specialized-level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. 

 
WHAT YOU’LL DO:

•    Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives.
•    Creates, reviews, and approves engineering changes.
•    Acts as a regulatory representative responsible for the review and analysis of applicable regulatory guidelines.
•    Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
•    Maintains pertinent domestic and international medical device regulations to ensure submission requirements worldwide are current, up-to-date, and are entered into regulatory submission database and file systems.  Ensures that information on such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel if requested.
•    Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
•    May interface directly with FDA and other regulatory agencies if so directed.
•    Review protocols and reports to support regulatory submissions.
•    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.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelor’s degree or an equivalent combination of education and experience
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment. 
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. 
• Multitasks, prioritizes and meets deadlines in timely manner. 
• Strong organizational and follow-up skills, as well as attention to detail. 

Preferred

• Bachelor’s degree or higher in a technical discipline (science, biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, math, engineering, etc.
• Experience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.
• Experience with medical device industry 
• Experience working in a broader enterprise/cross-division business unit model
• Ability to critically think through complex problem statements.
• Experience writing clear and concise technical documents.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)  
• Proficient with MS Office suite (Word, Excel, Outlook)

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives, and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs. Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and a history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is

$48,000.00 – $96,000.00

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

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

CRLB Core Lab

        

LOCATION:

United States > Irving : LC-8

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

No

     

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.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf