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Abbott Regulatory Affairs Specialist II in Scarborough, Maine

DO WORK THAT MATTERS

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions .

BUSINESS UNIT

The position of Regulatory Affairs Specialist II is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will prepare documentation for domestic and international product registrations for new and modified products.

The person hired in this role will perform the responsibilities outlined below:

  • Provide extended regulatory support for diagnostic product development and commercial diagnostic products.

  • Assist in developing regulatory strategies for products in development and for modified products to achieve clearance/approval in the US and internationally.

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

  • Compile and publish all material required for submissions, license renewals, and annual registrations.

  • Maintain approvals/licenses/authorizations for existing marketing authorizations.

  • Ensure compliant shipment of products through the maintenance of applicable inclusions, spreadsheets, etc.

  • May be responsible for yearly Establishment Registration and Product Listings with FDA and Annual Reporting to Health Canada. Ensures accuracy of US registration and device listing.

  • Add and maintain information contained in the Global Regulatory Information Database.

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

  • Develop internal procedures and tools.

  • Conduct informational or training sessions for stakeholders.

  • Organize and maintain hard copy and electronic department files.

  • Demonstrate 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.

REQUIREMENTS

  • Bachelor’s Degree in Biology, Chemistry, Biochemistry,Engineering or other related technical field (or the equivalent combinationof education and experience).

  • 4+ years of experience in a similar Regulatory Affairs role.

PREFERRED QUALIFICATIONS:

  • 1+ years’ experience in an IVD or medical device manufacturing environment.

  • Experience in International Regulatory Affairs

COMPETENCIES:

  • Good knowledgeof federal regulations.

  • Demonstratedwritten and verbal communication skills

  • Strong timemanagement skills, with the ability to work on multiple projectssimultaneously.

  • Ability to workindependently as well as within a team

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

AboutAbbott.

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

An equalopportunity employer, Abbott welcomes and encourages diversity in ourworkforce. We provide reasonable accommodation to qualified individuals withdisabilities. To request accommodation, please send an email to MyRecruiter@alere.com .

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

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