Regulatory Affairs Specialist II Heart Failure

4 days ago

Atlanta, Georgia, United States Abbott Laboratories company Full time
Job Title: Regulatory Affairs Specialist II Heart Failure

Abbott Laboratories 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.

As a Regulatory Affairs Specialist II in our Heart Failure Division, you will play a critical role in ensuring the regulatory compliance of our medical devices. You will work closely with cross-functional teams to prepare and submit regulatory applications, create and review engineering changes, and maintain pertinent domestic and international medical device regulations.

Key Responsibilities:
  • Prepare robust regulatory applications for FDA and international regulatory agencies 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 as needed.
  • 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 worldwide are current and up-to-date.
  • Support the product release process by creating GTS licenses or reviewing and approving requests for product release.
  • Review protocols and reports to support regulatory submissions.
Requirements:
  • Bachelor's Degree or an equivalent combination of education and work experience.
  • Minimum 3 years related experience, including a minimum of two years regulatory experience.
  • Experience with either 510(k) applications, PMA supplements, and US device regulations or with EU and other international medical device regulations and submissions.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

Abbott Laboratories is an Equal Opportunity Employer, committed to employee diversity. We offer a comprehensive benefits package, including medical coverage, retirement savings plan, tuition reimbursement, and education benefits. If you are a motivated and detail-oriented individual who is passionate about regulatory affairs, we encourage you to apply for this exciting opportunity.

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