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Lead Specialist in Regulatory Affairs

2 months ago

Santa Clara, California, United States Abbott Full time

Lead Specialist in Regulatory Affairs

Abbott stands as a prominent figure in the global healthcare sector, dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of transformative technologies encompasses various healthcare domains, featuring top-tier businesses and products in diagnostics, medical devices, nutritionals, and branded generic medications. With a workforce of 114,000 professionals, we cater to the needs of people across more than 160 nations.

Key Responsibilities:

  • Deliver regulatory insights to guide product lifecycle strategies
  • Evaluate the suitability of quality, preclinical, and clinical documentation for submission processes
  • Oversee the maintenance of annual licenses, registrations, and product listings
  • Analyze and submit change controls to assess the extent of changes and the necessary submission obligations

Required Qualifications:

  • Bachelor's Degree in a relevant discipline or an equivalent mix of education and professional experience
  • 3-4 years of experience within a regulated sector (such as medical products or nutritionals)
  • Exceptional organizational skills and meticulous attention to detail

Preferred Qualifications:

  • Bachelor's degree in a scientific or technical field (engineering, life sciences, mathematics)
  • Prior experience with PMA / IDE and international regulatory submissions
  • Capability to function effectively within a team and independently in a dynamic, fast-paced environment

Abbott is committed to fostering career growth opportunities while prioritizing employee well-being and promoting a diverse workplace. Join us in making a significant impact in the realm of global healthcare.