Dexcom Careers – Regulatory Affairs Specialist

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

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