Regulatory Affairs Specialist II Heart Failure

6 days ago


Pleasanton, California, United States Abbott Laboratories company Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Specialist II to join our Heart Failure Division at Abbott Laboratories. As a key member of our team, you will play a critical role in ensuring the regulatory compliance of our products and procedures.

Key Responsibilities
  • Prepare and submit regulatory applications to achieve departmental and organizational objectives.
  • Create, review, and approve engineering changes.
  • Act as a core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments.
  • Review and evaluate communications to ensure they convey all necessary detail and adhere to applicable regulatory standards.
  • Maintain pertinent domestic and international medical device regulations to ensure submission requirements are current and up-to-date.
  • Interface directly with regulatory agencies as needed.
Requirements
  • Bachelor's Degree or equivalent combination of education and work experience.
  • Minimum 3 years related experience, including a minimum of 2 years regulatory experience.
  • Experience with 510(k) applications, PMA supplements, and US device regulations or EU and other international medical device regulations and submissions.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Strong verbal and written communication skills.
What We Offer

As a Regulatory Affairs Specialist II at Abbott Laboratories, you will have the opportunity to work with a global healthcare leader that helps people live more fully at all stages of life. You will be part of a team that is dedicated to developing solutions to diagnose, monitor, and manage heart failure, allowing people to restore their health and get on with their lives.

We offer a competitive salary and benefits package, including medical coverage, retirement savings plan, tuition reimbursement, and education benefits. You will also have the opportunity to work with a diverse team of professionals and contribute to the development of innovative solutions that make a difference in people's lives.

Abbott Laboratories is an Equal Opportunity Employer committed to employee diversity. We are proud to be a company that values and respects the contributions of all our employees and strives to create an inclusive and supportive work environment.



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