What are the responsibilities and job description for the Regulatory Affairs Manager position at Abbott?
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.
Regulatory Affairs Manager
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 (https : / / www.abbott.com / corpnewsroom / strategy-and-strength / tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https : / / www.abbott.com / corpnewsroom / strategy-and-strength / college-degree-for-free-its-possible-with-freeu.html) 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 is based at the Abbott Park, IL (Lake Bluff, IL) or Willis Tower, IL (Chicago, IL) location within the Transfusion Medicine department. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
As the Regulatory Affairs Manager, you’ll be recognized as an expert and resource in regulatory affairs for domestic and international filings. Primarily, you will support worldwide regulatory approvals and registrations for blood screening products under the direction of the Regulatory Affairs Associate Director. Additionally, you will provide regulatory support to ensure compliance with all FDA and international regulatory requirements for all on-market blood screening products.
What You’ll Work On
Serves as a mentor for Regulatory Affairs associates and specialists.
Develops global regulatory strategies for new and modified products.
Prepares and submits FDA and international product registrations and licensing applications (original submission and subsequent product enhancements).
Critically evaluates design changes for regulatory impact; effectively tracks and communicates on-market product changes to regulatory agencies through FDA and international submissions.
Critically evaluates deviations that have potential to impact distributed CBER-licensed products.
Provides regulatory support for internal and external audits.
Reviews and advises on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations.
Interprets new or existing regulatory requirements as they relate to division products and procedures.
Maintains a professional demeanor and technical expertise through familiarity with the literature, attendance at professional meetings and participation in team meetings.
Serve as a mentor for Regulatory Affairs Coordinators, Associates, and Assistants.
Develop global regulatory strategies for new and modified products.
Participate in and provide input to project teams to assure that FDA and international product registrations and licensing applications (original submission and subsequent product enhancements.).
Required Qualifications
Bachelors Degree preferably in medical, science or engineering related discipline, or an equivalent combination of education and work experience is required.
Preferably 8 years experience in the medical device industry, with 5 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II, and III medical devices. and / or EU submissions.
Scientific writing experience is required.
Preferred Qualifications
Experience with EU submissions.
Ability to work effectively on project teams.
Must be able to juggle multiple and competing priorities.
Strong written, verbal, presentation, and organizational skills. Working knowledge of QSR, ISO, and EN standards.
Strong working knowledge of regulatory requirements for U.S., European community, Japan, Canada, and other countries.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : www.abbottbenefits.com (http : / / www.abbottbenefits.com / pages / candidate.aspx)
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.
The base pay for this position is $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
Salary : $97,300 - $194,700
