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MicroVention, Inc. Specialist, Regulatory Affairs in Aliso Viejo, California

9928BR

Title:

Specialist, Regulatory Affairs

Job Description:

This position is responsible for assisting in obtaining regulatory approvals and ensures compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Job duties:

  • Serves on product development and operations teams to ensure regulatory compliance.

  • Executes the regulatory plan for the assigned market(s) based on the approved regulatory strategy.

  • Writes various technical sections of the regulatory submission.

  • Prepares regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.

  • Integrates 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.

  • Reviews change order documents and ascertains impact on current regulatory approvals.

  • Reviews promotional material and labeling for regulatory compliance as assigned.

  • Maintains regulatory files and records.

  • Technical publishing of submissions.

  • Edits/revises Standard Operating Procedures.

  • Builds team cohesiveness by influencing and supporting team members.

  • Performs other duties and responsibilities as assigned.

Auto req ID:

9928BR

Location:

Aliso Viejo, California, USA

Department Name:

523-RAQA Regulatory

Qualifications:

  1. Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.

  2. One (1) to four (4) years of professional regulatory experience.

  3. Experience in the preparation of U.S. 510(k) submissions, PMA submissions and/or Design Dossier applications.

  4. Experience interfacing with relevant regulatory authorities through various stages of device life cycle.

Desired Qualifications

  1. Leading small teams.

  2. Ability to work well in a team environment.

  3. Detail oriented.

  4. Proven analytical abilities and organization skills.

  5. Ability to comprehend technical documents and concepts.

  6. Proficient computer skills (e.g., MS Office).

External-Facing Title:

Regulatory Affairs Specialist

Posting Country:

US - United States

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.

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