Monday , December 4 2023

Dexcom Careers – Regulatory Affairs Specialist

Website Dexcom

Job Description:

Collaborate with Regulatory Affairs Management and assist in regulatory activities and projects to successfully meet department and corporate goals.

Job Responsibilities:

  • Oversight of the regulatory agents’ activities
  • Corrections and Removals
  • Participation in the development of regulatory strategies and prepare regulatory submissions.
  • EU submissions include filing and amending Technical Files
  • Represent Regulatory Affairs on various cross-functional teams:
  • Evaluation and selection of regulatory agents
  • EMEA and LATAM submissions include filing and amending technical dossiers

Job Requirements:

  • Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations, quality control, auditing principles, and adverse event reports.
  • Must have strong writing, editing and analytical skills and have experience in developing complex submissions with minimal supervision.
  • Must have two to five years’ experience in a regulated medical device company with a minimum of two years in regulatory affairs, clinical affairs or quality assurance.
  • Must work well independently or within a cross-functional team environment.

Qualification & Experience:

  • Typically requires a Bachelors degree and a minimum of 2-5 years of related experience.

Job Details:

Company:  Dexcom

Vacancy Type:  Full Time

Job Location:  San Diego, CA, US

Application Deadline: N/A

Apply Here