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: 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. The Opportunity
This position works out of our Lake Forest, IL office with Rapid Diagnostics.
We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.
The Manager, Regulatory Affairs, will work in the Abbott Rapid Diagnostics Division. The main responsibility of this role is to combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required regulations. The person hired has an opportunity to execute highly complex and specialized projects as well as interface with regulatory agencies. This position does not have direct reports.
What You'll Work On
As the Manager, Regulatory Affairs, you will be responsible for assessing cumulative changes within the existing product portfolio, creating robust regulatory strategies, working with cross-functional teams as the regulatory SME, compiling regulatory submissions, and ensuring data is effectively presented for the registration of products worldwide.
What You'll Work On Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on regulatory requirements for in vitro diagnostic devices. Assess cumulative changes proposed or implemented for on-market products. Develop global regulatory strategies (Various international markets including working with FDA) and update based upon regulatory changes. Utilize technical regulatory skills to propose strategies on complex issues. Create project plans and timelines. Write and edit submission documents. Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions. Negotiate with regulatory authorities during the development and review process to ensure submission clearance/approval. Review and approve labeling to ensure compliance. Provide strategic input and technical guidance on regulatory authority queries. Perform submission risk assessment and provide guidance for how risk can be mitigated or lowered. Ensure that data are identified, obtained and effectively presented for the registration of products worldwide. Provide regulatory support for internal and external audits. Required Qualifications Bachelor's degree 5 years of experience in a regulated industry (e.g., medical products, in vitro diagnostics). 5 years of experience in regulatory 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. Preferred Qualifications Bachelor's degree in science, math, engineering, or medical fields. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Previous experience with 510(k) and CLIA waiver submissions and international registrations. Ability to work effectively on cross-functional teams.
* 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 and @AbbottGlobal.
The base pay for this position is
$95,000.00 - $190,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
CMI ARDx Cardiometabolic and Informatics
LOCATION:
United States > Lake Forest : J55
ADDITIONAL LOCATIONS: WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
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