Collaborate with Regulatory Affairs Management and assist in regulatory activities and projects to successfully meet department and corporate goals.
- 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
- 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.
Vacancy Type: Full Time
Job Location: San Diego, CA, US
Application Deadline: N/A