Specialist I, Regulatory Affairs

3 weeks ago

Aliso Viejo, United States MicroVention Full time
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:
  • 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.


Qualifications

  1. Minimum BA/BS degree in a scientific or technical discipline or relevant field of study. Advanced degree may offset medical device industry experience.
  2. Minimum of three (3) years of Medical device industry experience.
Desired Qualifications
  1. Minimum one (1) year Regulatory Affairs Experience.
  2. Leadership skills.
  3. Ability to work well in a team environment.
  4. Detail oriented.
  5. Proven analytical abilities and organization skills.
  6. Ability to comprehend technical documents and concepts.
  7. Proficient computer skills (e.g., MS Office).

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