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Specialist I, Regulatory Affairs
$72k-93k (estimate)
Full Time
2 Days Ago
MicroVention is Hiring a Specialist I, Regulatory Affairs Near Aliso Viejo, CA
Job Description
This position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Job duties:
This position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Job duties:
- Serves as a member on project teams completing tasks as assigned by the team.
- Aides in the execution of the regulatory plan for the assigned market(s) based on the approved regulatory strategy.
- Assists in preparing regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.
- Aides in integrating various sources of information into a uniform style and language for regulatory submissions.
- Documents, consolidates and maintains verbal and written communication with regulatory agencies.
- Maintains regulatory files and records.
- Assists in reviewing change order documents and ascertains impact on current regulatory approvals.
- Assists with technical publishing of submissions.
- Supports and contributes into editing/revising Standard Operating Procedures.
- Builds team cohesiveness by supporting team members.
- Performs other duties and responsibilities as assigned.
- Minimum BA/BS degree in a scientific or technical discipline or relevant field of study. Advanced degree may offset medical device industry experience.
- Minimum of three (3) years of Medical device industry experience.
- Minimum one (1) year Regulatory Affairs Experience.
- Leadership skills.
- Ability to work well in a team environment.
- Detail oriented.
- Proven analytical abilities and organization skills.
- Ability to comprehend technical documents and concepts.
- Proficient computer skills (e.g., MS Office).
Job Summary
JOB TYPE
Full Time
SALARY
$72k-93k (estimate)
POST DATE
06/18/2024
EXPIRATION DATE
07/01/2024
WEBSITE
microvention.com
HEADQUARTERS
ALISO VIEJO, CA
SIZE
500 - 1,000
FOUNDED
1997
TYPE
Private
CEO
CARSTEN SCHROEDER
REVENUE
$200M - $500M
INDUSTRY
Medical Technology
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About MicroVention
MicroVention is a medical device company that develops and markets neurovascular devices for the treatment of cerebral diseases.
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