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 Requirements :
- 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.
- Ability to work well in a team environment.
- Detail oriented.
- Proven analytical abilities and organization skills.
- Ability to comprehend technical documents and concepts.
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