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Regulatory Affairs Post Market 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 109,000 colleagues serve people in more than 160 countries.

Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. 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 position of **Regulatory Affairs Specialist I** is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will with general guidance, perform a variety of functions in support of domestic and international product registrations for new and modified products. This position will focus on post-market Regulatory Reporting only.

**WHAT YOU’LL DO**

+ Post-market Regulatory Reporting/Complaint Handling

+ Processes Reportability Determinations

+ Prepares and Submits Regulatory Reports for FDA and other OUS (Outside of US) Regulatory Bodies

+ Monitors progress of all ongoing complaint activities and MDRs to ensure the timely submissions

+ Assists in the preparation of regulatory body additional information requests.

+ Organizes and maintains hard copy and electronic department files.

+ Keeps informed of global regulatory information.

+ Assists in developing internal procedures and tools.

+ Carries out duties in compliance with established business policies.

+ Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.

+ Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

**EDUCATION AND EXPERIENCE YOU’LL BRING**

**Required**

+ Bachelor’s Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.

**COMPETENCIES:**

+ Knowledge of Federal Regulations

+ Demonstrated written and verbal communication skills

+ Strong time management skills, with the ability to work on multiple projects simultaneously

+ Ability to work independently as well as within a team

+ Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio

**WHAT WE OFFER**

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

+ **A fast-paced work environment** where your safety is our priority ( **Manufacturing roles only** )

+ Production areas that are **clean, well-lit and** **temperature-controlled** ( **Manufacturing roles only** )

+ **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

+ **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 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: http://www.abbottbenefits.com/pages/candidate.aspx

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 on Twitter @AbbottNews and @AbbottGlobal.

**An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.**

We provide reasonable accommodation to qualified individuals with disabilities.

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

Regulatory Affairs Post Market Specialist

Full time
Scarborough, ME

Published on 04/14/2021

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