Senior Regulatory Affairs Specialist

22 hours ago

GA United States Abbott Full time
About Abbott

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.

What We Offer
  • Career Development: Grow and learn with an international company where you can build the career you dream of.
  • Health and Wellness: Enjoy free medical coverage for employees* via the Health Investment Plan (HIP) PPO, and access to a range of health and wellness benefits.
  • Retirement Savings: Take advantage of an excellent retirement savings plan with high employer contribution.
  • Education Benefits: Pursue your education goals with tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit.
  • Recognition: Work for 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.
The Opportunity

We are seeking a Senior Regulatory Affairs Specialist to join our Heart Failure Division on-site in Atlanta, GA.

As an individual contributor, the Senior Regulatory Affairs Specialist will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions.

This new team member will assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide, as well as prepare and submit documentation needed for registrations worldwide.

Key Responsibilities
  • Act as a regulatory representative on core product development teams, communicating regulatory requirements and impact of regulations to project teams, and providing input related to FDA and international product registrations and licensing requirements.
  • Develop global regulatory strategies for new and modified products.
  • Prepare and submit PMA and IDE Submissions and Supplements, and work with international affiliates to compile and submit international product registrations and licensing applications.
  • Interpret new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
  • Review and advise on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations.
  • Maintain annual licenses, registrations, and listing information, and assist with compliance to product post-marketing approval requirements.
  • Support the product release process by creating GTS licenses or reviewing and approving requests for product release.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Comply with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, and governing procedures and processes.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Review protocols and reports to support regulatory submissions.
  • Create, review, and approve engineering change requests.
  • Act as liaison between the Company and the various regulatory agencies, and interface directly with FDA and Notified Bodies.
Requirements
  • Bachelor's Degree in a related field or an equivalent combination of education and experience.
  • 3-4 years' experience in a regulated industry (e.g., medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • Strong written, verbal, presentation, and organizational skills. Ability to write and edit technical documents.
  • Exercise good and ethical judgment within policy and regulations.
  • Ability to work effectively on project teams and maintain project plans and timelines.
  • Strong analytical and problem-solving skills.
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.
  • Master's degree in Regulatory Affairs and may be used in lieu of direct regulatory experience.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
  • Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
  • Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
  • Experience with medical device software requirements and software regulations.
  • Ability to identify risk areas and escalate issues as appropriate.

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