Regulatory Affairs Professional for Cardiac Rhythm Technologies

1 week ago


Los Angeles, California, United States Abbott Laboratories Full time
Company Overview

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our diverse 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 over 160 countries, dedicated to delivering innovative solutions that transform lives and make a meaningful difference in the world.

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our Cardiac Rhythm Management division in Sylmar, CA. This role will lead the preparation and submission for regulatory approvals and act independently to identify and resolve problems.

About the Role
  • Prepares robust regulatory applications to achieve departmental and organizational objectives.
  • Creates, reviews, and approves change orders.
  • Acts as a regulatory representative on core product development teams, communicating regulatory requirements and impact of regulations to the development team.
Responsibilities

This position will be responsible for:

  • Maintaining ongoing surveillance and analysis of domestic and international medical device regulations.
  • Ensuring submission requirements worldwide are current and up-to-date.
  • Reviewing device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
  • Supporting the product release process by creating GTS licenses or reviewing and approving requests for product release.
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree or equivalent combination of education and work experience.
  • Minimum 3 years' experience in a regulated industry (e.g., medical products, nutritionals).
  • Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization.
Benefits

We offer a competitive salary and benefits package, including:

  • A base pay range of $83,600.00 - $167,200.00.
  • Free medical coverage for employees via the Health Investment Plan (HIP) PPO.
  • An excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement and other employee development programs.


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