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Regulatory Affairs Specialist II

2 months ago

Atlanta, Georgia, United States Abbott Laboratories company Full time
About Abbott Laboratories

Abbott 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.

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist II to join our team in Atlanta, GA. As a key member of our Heart Failure Division, you will be responsible for performing specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications.

Key Responsibilities
  • Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
  • Creates, reviews and approves engineering changes.
  • Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
  • Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies.
  • Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
  • May interface directly with FDA and other regulatory agencies.
  • Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
  • Reviews protocols and reports to support regulatory submissions.
  • Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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.
Preferred Qualifications
  • Bachelor's Degree in a Science/Technical discipline (engineering, life sciences, mathematics).
  • Master's degree.
  • Experience working in a broader enterprise/cross-division business unit model.
  • Experience working in the Medical Device industry.
  • Regulatory Affairs Professionals Society Certification is a plus.

Abbott is an Equal Opportunity Employer, committed to employee diversity. We offer a competitive salary and benefits package, including a comprehensive health insurance plan, retirement savings plan, and tuition reimbursement program. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.