Principal Regulatory Affairs Specialist - Heart Failure (on-site)

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

We are seeking a Principal Regulatory Affairs Specialist to join Abbott’s Heart Failure Division on-site in Atlanta, GA.

As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting regulatory submissions in the US, EU and outside of US (OUS) geographies.

What You’ll Work On

• Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
• Develops global regulatory strategies for new and modified products.
• Prepares and submits PMA and IDE Submissions and Supplements. Works with international affiliates to compile and submit international product registrations and licensing applications.
• Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
• Reviews and advises on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations.
• Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, and governing procedures and processes.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Reviews protocols and reports to support regulatory submissions.
• Creates, reviews and approves engineering change requests.
• Acts as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.

Required Qualifications

• Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
• Experienced in regulatory submissions for in vitro diagnostic devices and/or medical devices.
• Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).

Preferred Qualifications

• 5-7 years’ experience in a regulated industry with a minimum of 3 of those years directly related to Class III Medical Devices.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• Ability to work effectively on project teams.
• Must be able to manage multiple and compe