Regulatory Affairs Intelligence Specialist

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.

     

JOB DESCRIPTION:

Working at Abbott 

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: 

• Career development with an international company where you can grow the career you dream of. 

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. 

• An excellent retirement savings plan with a high employer contribution 

• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. 

• A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. 

The Opportunity 

This position serves as the Medical Devices Regulatory Affairs (RA) Global Regulatory Compliance process lead; collaborates cross-functionally as needed and keeps MD informed of key global regulatory changes and status of assessment / implementation for compliance via the QMS Process.   

WHAT YOU’LL DO 

Global Regulatory Operations is seeking a Regulatory Affairs Intelligence Specialist to join our team in St. Paul, MN. 

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 including the US, EU, Canada, Australia, Brazil, Japan, 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 

  

Required Qualifications

• Bachelor’s Degree or an equivalent combination of education and work 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, manage and/or engage others to accomplish projects.         
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. 
• Strong organizational and follow-up skills, as well as attention to detail and focus towards improving quality.   
• Multitasks, prioritizes and meets deadlines in timely manner.      

Preferred Qualifications 

• Bachelor’s Degree in a Science/Technical discipline (engineering, life sciences, mathematics). 

• 2-4+ years’ experience in medical devices, or a regulated industry. Experience in a Regulatory or Quality role, a plus. 

• Experience in program management a plus 

• Experience with document management systems a plus 

• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society. 

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

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.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

$50,700.00 – $101,300.00

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

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

MD Medical Devices

        

LOCATION:

United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     

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