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Regulatory Affairs Expert II

2 months ago

Pleasanton, California, United States Abbott Full time

About Abbott

Abbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our extensive portfolio includes innovative technologies across diagnostics, medical devices, nutrition, and branded generic medicines, supported by a workforce of 114,000 professionals serving communities in over 160 countries.

Why Join Abbott?

At Abbott, you will have the opportunity to engage in meaningful work, pursue personal and professional growth, and maintain a healthy work-life balance. Our offerings include:

  • Career advancement opportunities within a globally recognized company.
  • Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.
  • A robust retirement savings plan with significant employer contributions.
  • Tuition reimbursement and educational benefits, including programs to assist with student debt.
  • A workplace celebrated for its diversity and inclusion, recognized as one of the best employers globally.

Position Overview

The **Regulatory Affairs Specialist II** will be part of our Heart Failure Division, contributing to the development of innovative solutions aimed at diagnosing, monitoring, and managing heart failure.

Key Responsibilities

  • Prepare comprehensive regulatory submissions for both FDA and international regulatory bodies to meet departmental and organizational goals.
  • Review and approve engineering modifications.
  • Participate as a core team member in evaluating regulatory guidelines and project assessments.
  • Ensure that all communications meet regulatory standards and provide necessary details.
  • Maintain up-to-date knowledge of domestic and international medical device regulations and ensure compliance across submissions.
  • Engage with regulatory agencies as needed.
  • Facilitate the product release process by managing licenses and approvals.
  • Review protocols and reports to support regulatory submissions.
  • Contribute to initiatives aligned with Quality Management Systems (QMS) and Environmental Management Systems (EMS).
  • Adhere to FDA and international regulations, company policies, and operational procedures while fostering collaborative relationships with colleagues and stakeholders.

Qualifications

  • Bachelor's Degree or equivalent combination of education and experience.
  • A minimum of 3 years of relevant experience, including at least 2 years in regulatory affairs.
  • Familiarity with 510(k) applications, PMA supplements, and US device regulations or EU and international medical device regulations.
  • Ability to thrive in a complex, matrixed environment.
  • Strong communication skills, both verbal and written, with the ability to engage effectively at all organizational levels.
  • Excellent organizational skills with a keen attention to detail.
  • Proficient in multitasking and prioritizing tasks to meet deadlines.

Preferred Qualifications

  • Bachelor's Degree in a Science or Technical field (engineering, life sciences, mathematics).
  • Master's Degree.
  • Experience in a cross-division business unit model.
  • Background in the Medical Device industry.
  • Certification from the Regulatory Affairs Professionals Society is advantageous.

Abbott is an Equal Opportunity Employer, committed to fostering a diverse workforce.