Regulatory Affairs Director

4 weeks ago


Lake Forest, Illinois, United States Abbott Full time
Job Summary

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.

As a Regulatory Affairs Director at Abbott, you will play a critical role in ensuring the company's products meet regulatory requirements and are approved for market. You will work closely with cross-functional teams to develop and implement regulatory strategies, prepare and submit product approval applications, and maintain expert knowledge of laws and regulations.

Main Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with laws and regulations
  • Prepare and submit product approval applications to regulatory agencies
  • Maintain expert knowledge of laws and regulations and communicate this knowledge to internal stakeholders
  • Work closely with cross-functional teams to align regulatory activities with business objectives
  • Direct staff in implementing regulatory strategy and preparing regulatory submissions
  • Resolve and/or facilitate resolution of problems, including identifying causes to prevent re-occurrence
Qualifications

Bachelor's Degree in a science, math, engineering, or medical field preferred or an equivalent combination of education and work experience

Minimum 10 years of progressive work experience in regulatory affairs or a related discipline in the medical device field

Experience in a regulated industry, such as diagnostics, medical products, and a strong understanding of clinical research and/or regulatory affairs

Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results

Ability to work effectively within a team in a fast-paced changing environment

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Ability to multi-task, prioritize and meet deadlines in a timely manner

Ability to plan strategically and work independently

Strong organizational, planning, and follow-up skills and ability to hold others accountable

Ability to travel approximately 15-25%, including internationally



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