Regulatory Affairs Specialist II - Structural Heart

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.

     

JOB DESCRIPTION:

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’ll also have access to:

·  Career development with an international company where you can grow the career you dream of.
·  Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
·  An excellent retirement savings plan with 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 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.

Structural Heart Business Mission: why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

The Opportunity

We are recruiting for a Regulatory Affairs Specialist II to join our team in our St. Paul, MN location. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory guidance to cross-functional partners in support of various programs.

What You’ll Work On

·  Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes.
·  Assist in assessing the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities.
·  Individuals execute and manage technical and scientific regulatory activities. Must function independently (with oversight) as a decision-maker on regulatory issues and must assure that deadlines are met.

Required Qualifications

·  Bachelor’s degree (or equivalent)
·  2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.  
·  Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
·  Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Preferred Qualifications

·  Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. 
·  Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)  
·  Proficient with MS Office suite (Word, Excel, Outlook)
·  Think analytically with good problem-solving skills.
·  RAPS Certification. 

Apply Now

* 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.

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
$57,300.00 – $114,700.00

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

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

SH Structural Heart

        

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