Project Manager - Regulatory Affairs

Created by: Abbott
Added: 02.09.2020

Advert description

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 107,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

Abbott Ireland Diagnostic Division – Longford

Abbott established a diagnostics manufacturing facility in Sligo in 1994 to manufacture blood-screening products and reagents. In 2004, Abbott’s operations in Ireland expanded with the opening of a second facility in Longford. The plant was first occupied in December 2004, and the first product (Architect® TSH) was launched in December of 2005. The Longford facility plays a key role in helping Abbott to meet the increasing global demand for diagnostic testing in areas such as infectious disease, cancer, thyroid and cardiovascular diseases. Abbott in Longford manufactures 18 diagnostic reagent products for thyroid function, fertility, and pregnancy, cardiology, renal and metabolic. Our products are manufactured to the highest standards of quality and are regulated by bodies such as the U.S. Food and Drug Administration and the International Organization for Standardization (ISO).

PURPOSE OF THE JOB

To act as regulatory representative (Regulatory Affairs Project Manager) for the REACH strategic program, coordination, prioritization and execution of for Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) regulatory activities related to products manufactured at all Abbott Diagnostic Division (ADD) sites and at Third Party Manufacturers.

Major Responsibilities

  • Ensure regulatory and compliance requirements are met for the REACH program.
  • Review and assess project plans with cross functional teams across all sites and Third Party Manufacturers. Develop, trace and communicate progress against deliverables.
  • Develop innovative approaches to regulatory project management and have keen foresight to anticipate activities and events that may cause a delay and implement action plan to prevent delay from occurring. Identify and communicate any project related issues to management team and develop contingencies.
  • Conduct and coordinate regulatory assessments, notifications for worldwide submission to support the REACH project and assist in audits where necessary.
  • Coordinate the creation and maintenance of Technical Documentation for the REACH program.
  • Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well at the Abbott Global and Technical standards.
  • Works independently or Individual Contributon
  • Ensure compliance with regulatory requirements for the Division

EDUCATION & COMPETENCIES

  • Bachelor’s degree in life science or closely related discipline is required OR relevant combination of education and experience.
  • Minimum of 5 years industry relevant experience in the medical device or a related industry. Less experience may be appropriate with advanced degree.
  • A minimum of 2 years Regulatory or related field experience is desirable. Demonstrates understanding of how the Regulatory function supports the business.
  • Excellent communication and team skills to interface with co-workers, other departments, other sites, Third Party Manufacturers and external regulatory agencies.
  • Demonstrates technical, business & project leadership competencies that drive results and continuous improvement.

Specific details

Type of Contract Full time
Preferred Education Bachelor's, Master's, Other
Level of Experience 2-5 years

Location

Ireland, Europe
Longford