Senior Regulatory Affairs Associate II

2 weeks ago


Santa Clara, 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 diverse portfolio includes innovative technologies across diagnostics, medical devices, nutritionals, and branded generic medicines, supported by a workforce of 114,000 professionals in over 160 countries.

Why Work at Abbott?

At Abbott, you will engage in meaningful work, foster personal and professional growth, and enjoy a supportive environment that values your well-being. Our employees benefit from:

  • Career advancement opportunities within a global organization.
  • Comprehensive medical coverage through our Health Investment Plan (HIP) PPO.
  • A robust retirement savings plan with significant employer contributions.
  • Tuition reimbursement and educational benefits, including programs designed to alleviate student debt.
  • A workplace recognized for its commitment to diversity and inclusion, as well as its accolades from Fortune as one of the most admired companies globally.

Mission of the Structural Heart Business

Our mission is to enhance health and improve life quality through innovative device solutions and management strategies for structural heart disease.

Position Overview

We are seeking a Regulatory Affairs Specialist II to join our team. This role involves supporting daily manufacturing and operational activities related to change control while providing regulatory guidance on team initiatives. The successful candidate will leverage foundational regulatory knowledge to assist in product and team support, as well as prepare regulatory submissions for both domestic and international entities.

Key Responsibilities

  • Collaborate with supervisory staff to execute regulatory requirements for product development and maintenance.
  • Implement regulatory strategies in alignment with division objectives.
  • Engage in the analysis of product changes and their implications for current submissions.
  • Share expertise and insights with team members to enhance departmental knowledge.
  • Prepare written communications clearly and concisely for diverse audiences.
  • Ensure compliance with Good Manufacturing Practices (GMP) and quality system effectiveness.

Qualifications

Required:

  • Bachelor's Degree or equivalent experience.
  • A minimum of 5 years of relevant work experience.

Preferred:

  • Degree in a technical field such as biology, chemistry, or engineering.
  • 5+ years of experience in the medical device sector.
  • 1-2 years of experience in regulatory affairs.
  • Strong communication skills for effective interaction with regulatory agencies.
  • Analytical thinking and problem-solving capabilities.

Join Abbott to explore diverse career opportunities that empower you to build a fulfilling future.



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