Regulatory Affairs Specialist II

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 Specialist II

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. Youll 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 high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors 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

The position of Regulatory Specialist II is within our Toxicology business based in Lake Forest, IL or Pomona, CA . In this role, you will work as part of the Regulatory Affairs department with direct responsibility for the preparation of documentation for domestic and/ or international product registrations for new and modified products, regulatory assessment of product changes, review and approval of labeling and advertising/promotional materials, approval of global product distribution, and maintenance of regulatory records and files.

What Youll Work On

• Provides extended regulatory support for diagnostic product and commercial diagnostic products

• Assists in developing regulatory strategies for products in county introduction, registration or applicable to achieve approval in the international countries

• Research scientific, technical and regulatory information in order to write submission documents

• Prepare and compile all material required for submissions, license renewals , no conformities and annual registrations

• Maintains approvals/licenses/authorizations for existing marketing authorizations

• Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards or other worldwide regulatory agencies to various international affiliates

• Adds and maintains information contained in the Global Regulato r 1y Information Database

• Assesses product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations

• Develops internal procedures and tools

• Conducts informational or training sessions for stakeholders

• Organizes and maintains hard copy and electronic department files

• Keeps informed of global regulatory information

• Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel

• Carries out duties in compliance with established business policies

• Demonstrates commitment to the development, implementation and effectiveness of Company 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 companys policies and practices

• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job

• Perform other duties & projects as assigned

Required Qualifications

• Bachelor's degree (BS/BA) in any science or equivalent experience

• Experience in Regulatory Affairs, Quality Affairs or life sciences with 1-2 years of progressively responsible positions

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

• Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor

• Must be detail-orientated, self-motivated and available for flexible scheduling

• Strong written and verbal communication, problem solving and motivational skills

Preferred Qualifications

• One to three years in an IVD or medical device manufacturing environment

• Good knowledge of federal regulations

• Good knowledge of product labeling and related requirements

• Good knowledge of quality systems in a regulated manufacturing environment

• SmartSheet

• Bilingual (Spanish) a plus

COMPETENCIES:

• Demonstrated written and verbal communication skills

• Ability to work independently as well as within a team

• Ability to work on multiple projects simultaneously

• Possess a high degree of accuracy and attention to detail

• Teamwork

• Communication

• Achieving results

Apply Now

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.

The base pay for this position is $60,000.00 $120,000.00. In specific locations, the pay range may vary from the range posted.