Senior Regulatory Affairs Specialist

4 weeks ago


Irving, Texas, United States Abbott Laboratories Full time
Job Summary

Abbott Laboratories is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices and pharmaceuticals.

About the Role

This is a challenging and rewarding role that requires a strong understanding of regulatory affairs, medical devices, and pharmaceuticals. You will work closely with cross-functional teams to develop and implement regulatory strategies, prepare and submit regulatory documents, and maintain compliance with regulatory requirements.

Key Responsibilities

  • Develop and implement regulatory strategies to ensure compliance with regulatory requirements and guidelines.
  • Prepare and submit regulatory documents, including 510(k) and PMA submissions.
  • Maintain compliance with regulatory requirements, including FDA regulations and international standards.
  • Collaborate with cross-functional teams to develop and implement regulatory strategies.
  • Provide regulatory guidance and support to product development teams.
  • Stay up-to-date with changes in regulatory requirements and guidelines.

Requirements

  • Bachelor's degree in science or a related field.
  • Minimum 3-4 years of experience in a regulated industry, preferably in regulatory affairs.
  • Strong understanding of regulatory affairs, medical devices, and pharmaceuticals.
  • Excellent communication and interpersonal skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.

What We Offer

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.
  • Recognition and rewards for outstanding performance.

How to Apply

If you are a motivated and detail-oriented individual with a passion for regulatory affairs, please submit your application, including your resume and cover letter, to our website.



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