Regulatory Affairs Professional

7 days ago


Santa Clara, California, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott is a global healthcare leader that empowers individuals to live their best lives. Our diverse portfolio of innovative technologies and solutions spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and pharmaceuticals.

Overview

We are committed to delivering high-quality products and services that improve patient outcomes and enhance the quality of life. Our team of dedicated professionals shares a passion for making a meaningful impact in the world.

Salary Range

The estimated salary range for this position is $65,900 - $131,900 per year, depending on location and experience.

Job Description

Job Summary: We are seeking an experienced Regulatory Affairs Specialist to join our team in Santa Clara, CA. As a key member of our regulatory department, you will be responsible for ensuring compliance with regulatory requirements and providing support for product submissions worldwide.

Main Responsibilities:

  • Analyze and prepare documentation for product registrations worldwide.
  • Collaborate with cross-functional teams to ensure efficient and compliant business processes.
  • Provide expert advice on regulatory strategies and guidance on compliance issues.
  • Conduct negotiations with government agencies on routine product-related issues.

Requirements:

  • Bachelor's degree or equivalent combination of education and work experience.
  • 2-3 years' experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas.
  • Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
  • Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.

Preferred Qualifications:

  • Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).

Benefits:

We offer a comprehensive benefits package, including health insurance, retirement savings plan, tuition reimbursement, and education assistance program.

About Us: Abbott is an Equal Opportunity Employer committed to diversity and inclusion. We are proud to be recognized as one of the most admired companies in the world by Fortune magazine.



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