Regulatory Affairs Specialist
$71,600–$119,300 year
On-siteSan Diego, California, United States
San Diego, California, United StatesOn-siteFull Time$71,600–$119,300 yearDoctorate Or Professional DegreeEnterprise
Full TimeDoctorate Or Professional DegreeEnterprise
Job Summary
Develop regulatory strategies and prepare submissions for Dexcom's Continuous Glucose Monitoring systems across the US, EU, and Canada. Review and approve product and promotional labeling for software, evaluate documentation against submission requirements, and represent Regulatory Affairs on cross-functional software teams. Collaborate with regional regulatory teams to develop global strategies and support developmental activities for Dexcom software products.
Required Qualifications
- Bachelor's degree
- 2-5 years of related experience
- Knowledge of US and international regulatory requirements including design control, medical device submission requirements, labeling and promotion regulations, and medical device quality systems
- Medical Device Software experience and/or knowledge, such as software development lifecycle, IEC 62304, and software classification
- Strong technical writing, editing, and analytical skills
- Ability to work well independently and with cross-functional teams
- Proficiency in problem solving, proactive learning, organization, and excellent communication skills
- Ability to thrive in a fast-paced environment and adapt quickly to changing priorities
- Must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km)
Desired Qualifications
- Previous experience with 510(k) submissions, Health Canada submissions, or EU Medical Device Regulation
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