Regulatory Affairs Director

7 days ago

San Diego, California, 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. 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.

Job Summary

This position has primary management responsibility for the preparation and submission of product approval applications. The successful candidate will work with regulatory agencies to obtain timely approvals of all products, recommend, interpret, and implement company-wide policies and procedures, and ensure employee compliance with such policies, practices, and procedures.

Main Responsibilities
  • Develop and execute an effective regulatory strategy and direct the preparation of submissions for products to regulatory agencies.
  • Provide guidance on regulatory requirements and strategies to product development project teams and MCSO.
  • Maintain expert working knowledge of laws, regulations, and industry trends that impact company operations and decision-making.
  • Consult with and provide advice to senior management on strategies and plans for regulatory product approvals.
  • Direct staff in implementing regulatory strategy and preparing regulatory submissions.
  • Remain current on developments in the field of regulatory affairs and train staff on changing regulations.
  • Resolve and/or facilitate the resolution of problems, including identifying causes to prevent re-occurrence.
Qualifications

Bachelor's Degree in a science, math, engineering, or medical field is preferred. A Master's or Doctorate Degree is also preferred. Minimum 10 years of progressive work experience in regulatory affairs or a related discipline in the medical device field is required. Experience in a regulated industry and prior experience in medical devices and regulatory affairs are preferred.

Strong leadership skills, including the ability to set goals and provide positive and constructive feedback, are essential. Ability to work in a highly matrixed and geographically diverse business environment is also required. Strong verbal and written communication skills, ability to multi-task, prioritize, and meet deadlines, and ability to plan strategically and work independently are necessary.

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